The regulatory landscape for novel foods continues to evolve, with FSANZ recently calling for submissions on Application A1341 Cell-Cultured Duck Biomass. The application proposes an amendment to the Food Standards Code to permit the sale of cell-cultured duck as a novel food, representing another significant milestone in the emerging alternative protein sector.
As with previous cell-cultured food applications, FSANZ has undertaken a comprehensive pre-market safety assessment, evaluating production methods and manufacturing controls, microbiological and chemical safety, nutritional composition, potential risks and dietary impact.
FSANZ’s preliminary assessment has concluded that, when produced in accordance with the proposed specifications, the ingredient does not raise public health or safety concerns and is suitable for inclusion in the Food Standards Code. The application is now open for public consultation before a final decision is made.
The commercial availability of cell-cultured foods in Australia remains limited, with the regulatory pathway becoming increasingly established. Food businesses developing, importing or considering future use of cultivated ingredients should monitor these applications closely, as each approval helps define the regulatory expectations for this emerging category.
Compliance considerations by businesses should ensure they are prepared to demonstrate robust evidence. This is achieved by supporting the safety of the ingredient through comprehensive documentation of manufacturing processes and quality controls, appropriate traceability throughout the production chain, compositional specifications and conditions of use.
A key regulatory principle is that food labels must not be false, misleading or deceptive. This means businesses will need to ensure that product names and descriptions accurately reflect the nature and production method of cell-cultured foods, enabling consumers to make informed purchasing decisions. This ensures consumers have accurate product descriptions and labelling that meet all applicable regulatory requirements.
FSANZ has included their application and provisions that must be applied. Division 2 of Standard 1.5.4 sets out the following general labelling requirements for cell-cultured foods: Section 1.5.4-5 applies to food for sale that has a cell-cultured food as an ingredient and requires that, for the labelling provisions in Standard 1.2.1, ‘information relating to cell-cultured food’ requires the use of either ‘cell-cultured’ or ‘cell-cultivated’ in conjunction with the name of the ingredient that is a cell-cultured food.
Interest in cultivated proteins continues to grow internationally, with regulators balancing innovation alongside consumer confidence and food safety. As additional applications are assessed, businesses should expect further guidance around regulatory expectations, product naming, labelling and market authorisation processes.
Get in touch with our regulatory team to see what this could mean for your brand and future production.
