Announcement date
The Food Standards Australia New Zealand (FSANZ) Board approved Proposal P1055 - Definitions for gene technology and new breeding techniques on 4 June 2025 and on 25 July 2025 at the Food Ministers’ Meeting, Ministers agreed to not seek a review.
Link to announcement
The announcement can be found in the communiqué of outcomes from the Food Ministers' Meeting held on 25 July 2025. The approval report and supporting document can be found on the FSANZ web page for Proposal P1055.
Problem being addressed
The emergence of New Breeding Techniques (NBTs) has generated uncertainty about the regulatory status of foods derived from NBTs (NBT food). NBTs are a new technology that can make genetic changes similar to both older genetic modification techniques, as well as conventional breeding.
The Food Standards Code (the Code) contains definitions for ‘gene technology’ and ‘food produced using gene technology’ that determine whether or not a food is Genetically Modified (GM) and requires a safety assessment before they are allowed into the market. A review by FSANZ in 2017-2019 considered how these definitions apply to NBT food.
The review found that the current definitions are no longer fit for purpose. It identified scenarios where the Code could be interpreted inconsistently, including the risk that some NBT foods may inappropriately enter the marketplace without pre-market assessment and approval. This regulatory uncertainty may dissuade industry investment and be detrimental to consumer confidence in the safety of the food supply.
Proposal
The Decision Regulation Impact Statement (Decision RIS) considers an approach to amend the definitions in the Code to clarify when pre-market assessment and approval is required, and to ensure regulatory requirements remain proportionate to risk.
The Decision RIS considers the following options:
- Option 1: Status Quo
- Option 2: (Preferred) Amend the definitions in the Code to an outcomes-based definition based on the presence of novel DNA.
Under the preferred Option 2, it is anticipated there may be a small administrative cost to industry relating to familiarisation with the new definitions. There may also be a perceived decrease in informed choice for consumers. This is due to NBT foods not being subject to mandatory GM labelling unless they contain novel DNA or novel protein. However, closing regulatory gaps to ensure adequate and appropriate capture of NBT foods for pre-market approval is considered a risk-proportionate approach that protects public health and safety.
The regulatory certainty provided by the new definition is expected to incentivise investment and innovation in new food developments and productivity for food producers over the medium to long term. Consumers may directly benefit from this in terms of access to additional food choices that may have superior nutrition, convenience, and taste.
Assessed Impact Analysis outcome
Compliant Decision RIS.
The OIA considers that the consultation that has been undertaken to date is equivalent to a Consultation Regulation Impact Statement (Consultation RIS) under the Regulatory Impact Analysis Guide for Ministers Meetings and National Standard Setting Bodies (the Guide), as such only a Decision RIS was required. FSANZ provided the OIA with a letter outlining how the consultation process was equivalent to a Consultation RIS.