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 A1074 which seeks to reduce the minimum requirement for L‑histidine in infant formula products from 12 mg/100 kJ to 10 mg/100 kJ. The Authority considered the Application in accordance with Division 1 of Part 3 and has approved a draft variation to Standard 2.9.1 – Infant Formula Products.
Following consideration by the COAG 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 a draft variation to Standard 2.9.1 to require the presence of L‑histidine in infant formula products, specifically infant formula, follow-on formula and infant formula products for special dietary use, at a reduced minimum level of 10 mg/100 kJ.
A minimum requirement for L-histidine of 10 mg/100 kJ is safe and supports adequate growth in formula-fed infants. The reduced level also promotes consistency between domestic and international regulations and supports global trade of infant formula products with an overall net benefit to the community.
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 A1074 included one round of public consultation following an assessment and the preparation of a draft variation to Standard 2.9.1 and an associated report. Submissions were called for on 8 November 2012 for a six-week consultation period.
A Regulation Impact Statement was not required because the proposed variation to Standard 2.9.1 is 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. Variations
6.1 Item [1.1]
Item [1.1] replaces the existing minimum requirement for L-histidine in infant formula products of 12 mg/100 kJ, as it appears in the Table to clause 22, with a reduced level of 10 mg/100 kJ in the same Table. The minimum requirement will continue to apply to infant formula products currently regulated under Division 2 of Standard 2.9.1, specifically infant formula and follow-on formula.
6.2 Item [1.2]
Item [1.2] replaces the existing minimum requirement for L-histidine in infant formula products for special dietary use of 12 mg/100 kJ, as it appears in the Table to clause 32, with a reduced level of 10 mg/100 kJ in the same Table. The amended requirement will continue to apply to infant formula products for special dietary use, as currently regulated under Division 3 of Standard 2.9.1.
[1] Previously known as the Australia and New Zealand Food Regulation Ministerial Council
Overview
The Food Standards Australia New Zealand Act 1991 (FSANZ Act) governs the establishment and maintenance of food standards in Australia and New Zealand, with Food Standards Australia New Zealand (FSANZ) acting as the central regulatory body. The Act was introduced to ensure that food standards are based on sound scientific evidence and to maintain public health and safety. FSANZ is tasked with developing standards and variations to these standards, including the approval of applications for such changes, as outlined in Division 1 of Part 3 of the Act. In response to an application to lower the minimum requirement for L-histidine in infant formula products, FSANZ approved a draft variation reducing this requirement from 12 mg/100 kJ to 10 mg/100 kJ, following public consultation and consideration of its safety and benefits. This legislative instrument is exempt from compatibility with human rights statements as it is a non-disallowable instrument under section 94 of the FSANZ Act. The purpose of this variation is to ensure that the minimum requirement for L-histidine in infant formula products remains safe and supportive of adequate growth in formula-fed infants while aligning with international standards and promoting global trade.
Scope and Application
The legislation in question pertains to the Food Standards Australia New Zealand Act 1991, which authorises Food Standards Australia New Zealand (FSANZ) to develop and vary standards for inclusion in the Australia New Zealand Food Standards Code. FSANZ has accepted an application to reduce the minimum requirement for L-histidine in infant formula products from 12 mg/100 kJ to 10 mg/100 kJ. This legislative instrument applies to manufacturers and suppliers of infant formula, follow-on formula, and infant formula products for special dietary use, ensuring that these products meet the new minimum requirement for L-histidine. The legislative instrument operates within the Commonwealth jurisdiction, as FSANZ is a Commonwealth authority established under the FSANZ Act. There are no exclusions or exemptions mentioned in the explanatory statement, implying that the variation applies universally to all relevant products within the specified categories. The legislation does not extend or restrict application through subordinate instruments as per the provided explanatory statement.
Key Provisions
The primary operative sections of this legislation involve the approval of a draft variation to Standard 2.9.1 concerning the minimum requirement for L-histidine in infant formula products (Item [1.1] and Item [1.2]). These sections detail the reduction of the minimum requirement for L-histidine from 12 mg/100 kJ to 10 mg/100 kJ for infant formula, follow-on formula, and infant formula products for special dietary use. The changes are aimed at ensuring the safety of these products while aligning domestic standards with international regulations.
The obligations imposed by the Act require the Authority to develop and vary food regulatory measures, including standards, following the procedure outlined in Division 1 of Part 3 of the FSANZ Act. This includes considering applications such as Application A1074 and conducting public consultations as necessary. The Authority must also publish a notice regarding the draft variation of a standard as per section 92 of the FSANZ Act, ensuring transparency and public awareness. Notably, the variation is a legislative instrument but does not undergo parliamentary disallowance or sunsetting under the Legislative Instruments Act 2003, as per section 94 of the FSANZ Act.
In terms of compliance, breaches of the new standards regarding the minimum L-histidine requirement in infant formula products could have significant implications. Although the explanatory statement does not explicitly outline specific offences or penalties for non-compliance, it is implied that failure to adhere to the new standards could result in legal consequences. These might include fines, enforcement actions, or other regulatory penalties, depending on the severity and frequency of the non-compliance. The precise penalties would be governed by the relevant sections of the FSANZ Act and any other applicable legislation.
The legislation ensures that the Authority has followed due process in considering the application and has made a determination that the reduced L-histidine requirement is safe and beneficial. Public consultation was conducted to gather input and ensure that the interests of stakeholders were considered. The absence of a Regulation Impact Statement suggests that the variation is expected to have a minor impact on business and individuals. This careful consideration and consultation process are integral to maintaining public trust and ensuring the safety and quality of infant formula products.