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.
The Authority prepared Proposal P1039 to include food safety microbiological criteria for infant formula in Schedule 27- Microbiological limits in food. These criteria align with international (Codex) standards. The Authority considered the Proposal in accordance with Division 2 of Part 3 and has approved 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 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 variation to Standard 1.1.2 and Schedule 27 to align the Code’s food safety microbiological criteria for powdered infant formula products with international (Codex) standards.
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 P1039 included one round of public consultation following an assessment and the preparation of a draft variation to the Code and an associated report. Submissions were called for on 9 October 2015 for a six-week consultation period.
A Regulation Impact Statement was not required because the proposed variations to Standard 1.1.2 and Schedule 27 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 subsection 1.1.2—2(3) of Standard 1.1.2 by replacing the definition for SPC. The new definition reflects the variation made by item [2.2] below, which removes the limit for SPC in powdered infant formula from the Code.
Item [2] varies Schedule 27.
Item [2.1] replaces the Note to section 27—2 to reflect the variation made by item [1] above. The new Note refers to the amended definition of SPC in subsection 1.1.2—2(3) of Standard 1.1.2.
Item [2.2] omits section S27—3. Section S27—3 provides that the limit for SPC in section S27—4 does not apply to powdered infant formula products that contain lactic acid producing microorganisms. This exemption is no longer required as item [2.3] removes the limits for SPC in powdered infant formula products from the Code.
Item [2.3] replaces the table to section S27—4. The new table:
- separates the microbiological limits for powdered infant formula products into two new food categories: powdered infant formula products and powdered follow-on formula
- removes the current limits specified in the table for Coliforms, Coagulase-positive staphylococci, Bacillus cereus and SPC in respect of these foods
- amends the sampling plan for Salmonella in these foods by replacing 10 with 60 in Column 2(n) in the table
- inserts new limits for Cronobacter in powdered infant formula products, where the number of sample units (n) is 30, the acceptable microbiological limit (m) is ‘not detected in 10g’, and the number of sample units allowed to exceed that acceptable microbiological limit (c) is 0. These limits do not apply to powdered follow-on formula.
The stock-in-trade exemption provided by section 1.1.1—9 of Standard 1.1.1 does not apply to any of the above variations. See clause 3 of the instrument.
Overview
The Food Standards Australia New Zealand Amendment Regulations 2016 (F2016L00784) were enacted to align the Australia New Zealand Food Standards Code's food safety microbiological criteria for powdered infant formula products with international (Codex) standards. This was achieved by modifying Standard 1.1.2 and Schedule 27, thereby updating the existing microbiological criteria. The purpose of these regulations was to enhance the safety and quality of infant formula products, ensuring they meet globally recognised standards. The enacting body was the Food Standards Australia New Zealand Authority, which prepared the proposal in accordance with the Food Standards Australia New Zealand Act 1991 and consulted the public as stipulated by the Act. The policy objective was to safeguard public health by implementing stricter microbiological criteria, thereby reducing potential health risks associated with the consumption of powdered infant formula products.
Scope and Application
The explanatory statement outlines a legislative instrument that pertains to the Food Standards Australia New Zealand Act 1991, specifically addressing the variation of food safety microbiological criteria for powdered infant formula products. This legislative instrument applies to entities involved in the production, importation, and sale of powdered infant formula products within Australia and New Zealand, aligning the criteria with international standards set by Codex. The geographic scope of this legislation is national, covering both Australia and New Zealand, as it involves the Australia New Zealand Food Standards Code. The proposed variations are exempt from parliamentary disallowance or sunsetting under the Legislation Act 2003, as specified by section 94 of the FSANZ Act. The changes include modifying the definition of Specific Pathogenic Contaminants (SPC) and removing certain microbiological limits for powdered infant formula products, thereby reflecting updated international standards. This legislative instrument does not incorporate any documents by reference and was developed following a round of public consultation, which indicated a minor impact on business and individuals, hence no Regulation Impact Statement was required. The variations do not necessitate a statement of compatibility with human rights, as they fall under the category of non-disallowable instruments.
Key Provisions
The legislation (F2016L00784) primarily addresses the variation of food safety microbiological criteria for powdered infant formula products in the Australia New Zealand Food Standards Code. Section 13 of the Food Standards Australia New Zealand Act 1991 (FSANZ Act) outlines the Authority’s responsibility for developing standards, and the procedure for considering a proposal for the development or variation of food regulatory measures is specified in Division 2 of Part 3 of the FSANZ Act. Proposal P1039, which aligns with international Codex standards, was considered by the Authority, leading to the approval of a draft variation to Standard 1.1.2 and Schedule 27. This variation aims to update the microbiological criteria for powdered infant formula products, reflecting current international standards.
The obligations imposed by this legislation include the requirement for the Authority to publish a notice about the draft variation of a standard as per section 92 of the FSANZ Act. The Authority must also adhere to the consultation process outlined in Division 2 of Part 3 of the FSANZ Act, which involves public consultation and the preparation of a draft variation to the Code and an associated report. Submissions for this consultation period were called for on 9 October 2015, allowing for a six-week period of public feedback. This process ensures that the Authority considers stakeholder input before finalising the variation.
Under section 94 of the FSANZ Act, the approved variation is classified as a legislative instrument, but it is not subject to parliamentary disallowance or sunsetting under the Legislation Act 2003. Consequently, the variation becomes legally binding and enforceable once published. The Authority must ensure that the variation is implemented in accordance with the specified timeline and that relevant stakeholders are informed of the changes. Failure to comply with these obligations may result in non-compliance with the Code and potential enforcement actions.
The legislation also outlines the potential consequences for breach of the food safety microbiological criteria. While the explanatory statement does not explicitly detail specific offences or penalties, non-compliance with the new standards could result in regulatory action under the FSANZ Act. This may include fines, enforcement actions, or other regulatory measures to ensure compliance with the updated standards. The exact penalties would depend on the nature and severity of the breach, as well as any relevant state or territory legislation that may apply. It is important for manufacturers and other relevant parties to adhere to the new standards to avoid any legal or financial repercussions.