Announcement date
The Food Standards Australia New Zealand (FSANZ) Board approved Proposal P1028 – Infant Formula on 4 June 2024 and on 25 July 2024 at the Food Ministers’ Meeting, Ministers agreed to not seek a review.
The revised regulation for infant formula products came into effect on 13 September 2024 and applies in Australia only. New Zealand has opted out of this Standard under Annex D of The Agreement between the Government of Australia and the Government of New Zealand Concerning a Joint Food Standards System.
Link to announcement
The announcement can be found on the FSANZ web page for Proposal P1028, alongside the Approval Report and Supporting Documents.
Problem being addressed
Proposal P1028 was prepared in 2013 to review the regulation of infant formula products (Standard 2.9.1 – Infant Formula). Proposal P1028 is large and complex, with the final draft variation including amendments to eight Standards and five Schedules to the Code.
The objectives of Proposal P1028 were to ensure that infant formula products continue to be safe and suitable while also taking account of the latest scientific evidence, market developments, changes in the international regulatory context, and revised Australian and New Zealand policy guidance.
While the current standards for infant formula products are on a whole functioning as intended, there are some areas which are regarded as out-of-date with current scientific knowledge, not harmonised with international and overseas regulations, and in some respects difficult to interpret.
The review ensured that infant formula products remain safe and suitable and provided an opportunity to ensure the regulation is modernised and fit for purpose.
Proposal
The Decision Regulatory Impact Statement (DRIS) considered the following options:
- Option 1: Status Quo
- Option 2: A package of amendments to the Code that clarify the regulatory framework and regulatory requirements for infant formula products, amend product categories and update product labelling requirements.
The DRIS identified Option 2 as the preferred option.
The options are summarised at a high level in the DRIS. Full descriptions of the proposed changes are provided in the Approval Report (which can be viewed on the P1028 website) along with the full text of the proposed changes to the Code.
OIA’s assessment is that the RIS was adequate to inform a final decision with the requirements of the Regulatory Impact Analysis Guide for Ministers’ Meetings and National Standard Setting Bodies.
Assessed Impact Analysis outcome
Compliant Decision RIS