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.
The Authority accepted Application A1173 which seeks to lower the minimum protein requirement in all regular follow-on formula. The Authority considered the Application in accordance with Division 1 of Part 3 and has prepared a draft Standard.
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 approved a draft amendment to paragraph 2.9.1—9(2)(b) in Standard 2.9.1 to: permit a lower protein minimum in milk-based follow-on formula; and retain the current minimum for all other follow-on formulas with the exception of follow-on formula for special dietary use based on a protein substitute. The protein compositional requirements for an infant formula product for special dietary use based on a protein substitute are imposed by section 2.9.1—15 and not by paragraph 2.9.1—9(2)(b).
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 A1173 included one round of public consultation following an assessment and the preparation of a draft variation Standard and associated assessment summary and report. Submissions were called for on Thursday 16 May 2019 for a four-week consultation period.
A Regulation Impact Statement was not required because the proposed variations to Standard 2.9.1 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 [1.1] varies paragraph 2.9.1—9(2)(b) of Standard 2.9.1 by omitting the existing paragraph and substituting a new paragraph.
The new paragraph will require: a milk-based follow-on formula to have a protein content of no less than 0.38 g/100 kJ and no more than 1.3 g/100 kJ; and all other follow-on formulas – with the exception of follow-on formula for special dietary use based on a protein substitute – to have a protein content of no less than 0.45 g/100 kJ and no more than 1.3 g/100 kJ.
The new paragraph will not prescribe the protein content for follow-on formula for special dietary use based on a protein substitute. This is because section 2.9.1—9(2) does not set the protein content for the latter. Instead, section 2.9.1—15 currently sets the compositional requirements for infant formula products, including follow-on formula, that are for special dietary use based on a protein substitute. Paragraph 2.9.1—15(2)(c) currently requires these products to have a protein content of no less than 0.45g/100kJ and no more than 1.4g/100kJ.
Item [1.2] inserts a note after section 2.9.1—9(2) of Standard 2.9.1. This note is to assist the reader and advises that section 2.9.1—15 – as opposed to section 2.9.1—9(2) – sets the protein content for infant formula and follow-on formula that are for special dietary use based on a *protein substitute.
Overview
The Food Standards Australia New Zealand Amendment Regulation 2019 (F2019L01576) was enacted to amend the minimum protein requirements for regular follow-on formula in Australia and New Zealand. This regulation was introduced to address the need to lower the minimum protein content in milk-based follow-on formula while retaining the current protein content for other types of follow-on formula, except for those specifically designed for special dietary use based on a protein substitute. The regulation was enacted by the Australian Government through the authority granted by the Food Standards Australia New Zealand Act 1991 (FSANZ Act), and the policy objective is to provide flexibility in the nutritional requirements of follow-on formula to better meet the needs of infants transitioning from infant formula to regular food.
The regulation was developed following public consultation and an assessment by Food Standards Australia New Zealand, and it was reviewed by the Australia and New Zealand Ministerial Forum on Food Regulation before being published as a legislative instrument. The variation is not subject to parliamentary disallowance or sunsetting, in accordance with the FSANZ Act. This regulatory change aims to ensure that the protein content in follow-on formula is appropriate for the nutritional needs of infants while allowing for some flexibility in the formulation of these products.
Scope and Application
The F2019L01576 legislation pertains to amendments in the Australia New Zealand Food Standards Code (the Code) regarding the protein content in follow-on formula products. This Act applies to food businesses, manufacturers, and entities involved in the production, distribution, and sale of milk-based and other follow-on formula within Australia and New Zealand. The legislative instrument, a variation to Standard 2.9.1, aims to modify the minimum protein requirements for milk-based follow-on formula while retaining the existing standards for other types of follow-on formula, except those intended for special dietary use based on a protein substitute. The amendment does not affect the protein compositional requirements for special dietary use formulas, which are governed by a different section of the Code. This legislative change extends across both Australia and New Zealand, operating under the jurisdiction of Food Standards Australia New Zealand (FSANZ), which has the authority to implement and enforce these standards. The Act itself is a non-disallowable instrument, exempt from parliamentary disallowance or sunsetting, and does not incorporate any documents by reference. Public consultation was conducted as part of the process to consider the application for variations, and the impact of these changes is expected to be minor.
Key Provisions
The key operative sections of this legislation pertain primarily to the variation of the protein content requirements in follow-on formulas (sections 2.9.1—9(2)(b) and 2.9.1—15). Specifically, section 2.9.1—9(2)(b) of Standard 2.9.1 has been amended to allow for a lower protein minimum in milk-based follow-on formula, while retaining the current minimum for all other follow-on formulas, except those for special dietary use based on a protein substitute (Item [1.1]). Additionally, a note has been inserted after section 2.9.1—9(2) to clarify that the protein content for special dietary use formulas is governed by section 2.9.1—15 rather than section 2.9.1—9(2) (Item [1.2]).
The obligations imposed on the parties governed by this Act include the requirement for the Authority to publish a notice about the standard or draft variation of a standard (section 92 of the FSANZ Act). This involves considering applications for the development or variation of food regulatory measures, conducting public consultation, and preparing associated assessment summaries and reports. The Authority must also ensure that any new or varied standards are compatible with existing legislation, particularly in relation to special dietary use formulas, which are governed by different provisions.
Failure to comply with the requirements set out in this Act may result in regulatory action. However, the explanatory statement does not detail specific offences, penalties, or consequences for breach. The legislative instrument itself, being a non-disallowable instrument under section 94 of the FSANZ Act, is not subject to parliamentary disallowance or sunsetting. The Authority’s role in ensuring compliance with food standards and the impact of non-compliance would typically involve enforcement measures that are not explicitly outlined in the provided text.
Given that the variations to Standard 2.9.1 are deemed to have a minor impact on business and individuals, a Regulation Impact Statement was not required (section 4). This suggests that the anticipated consequences of non-compliance are likely to be relatively minor, focusing on ensuring that the new standards are adhered to in the manufacturing and labelling of follow-on formulas. The Authority's enforcement actions would likely involve ensuring that manufacturers comply with the new protein content requirements, rather than imposing significant penalties on non-compliance.