Eden Brew achieves Australian first as FSANZ accepts application for precision-fermented beta-casein

Eden Brew’s submission to Food Standards Australia New Zealand (FSANZ) for its precision-fermented beta-casein has been formally accepted for assessment, marking the first time a non-animal milk protein has entered the regulatory pathway in Australia and New Zealand. The company described the milestone as a significant step forward for both its own commercial plans and the wider precision-fermentation sector.

The application covers Eden Brew’s Beta-casein Protein Preparation, known as BCPP1, a novel ingredient produced via precision fermentation using a genetically modified strain of Komagataella phaffii. Designed as a high-quality functional protein, the preparation contains A2 beta-casein nutritionally equivalent to the bovine counterpart and is intended for use in a wide range of food products as an alternative to conventional dairy and plant proteins.

FSANZ has placed the submission into a General Level 5 procedure, which includes a single public consultation planned for April-May 2026. The regulator estimated that the assessment would take up to 668 hours, with completion expected by mid-November 2026. Eden Brew said the anticipated one-year timeline compared favorably with other jurisdictions and demonstrated the maturity of the regulatory framework for evaluating novel proteins in Australia.

Acceptance for assessment indicates that FSANZ is satisfied the submission meets the high-level requirements set out in its application handbook. Eden Brew said this reflected the depth of scientific work underpinning the dossier, including safety studies, protein characterization, and manufacturing controls. “A tremendous amount of work and scientific rigour has gone into reaching this point. Acceptance into assessment signals that FSANZ is satisfied our submission meets all high-level requirements; which is a major achievement and a testament to the depth of our science, our safety data, and our team’s relentless focus,” the company said.

The application seeks a variation to Standard 1.5.2 – Food produced using gene technology – to permit the sale of BCPP1, along with an accompanying amendment to Schedule 3 to establish an ingredient specification. According to Eden Brew, the protein preparation has been evaluated through a comprehensive safety assessment covering host and donor organism history, genetic stability, composition, digestibility, and allergenicity.

The company reported that K. phaffii, the host organism, has a long record of safe use in food production and holds Qualified Presumption of Safety status in Europe. Whole-genome sequencing confirmed precise integration of the inserted genetic material without unintended modifications or residual antibiotic resistance markers. Protein-quality analysis showed that the preparation, which comprises approximately 25% A2 beta-casein and 75% co-purified host cell proteins, matched the protein quality of conventional beta-casein when assessed using PDCAAS.

Eden Brew also noted that there was no evidence of toxicity or novel allergenicity based on bioinformatic comparisons. Because beta-casein is a known milk allergen, the ingredient will be labeled accordingly. Dietary-exposure modelling for Australia and New Zealand indicated that intake remained within safe limits even at the highest consumption scenarios.

The company framed the submission as part of a broader trend driven by consumer interest in sustainable, animal-free foods. Precision fermentation, it said, offers an efficient way to produce consistent, functional proteins while reducing reliance on resource-intensive production systems. If approved, BCPP1 would expand the options available to food manufacturers seeking to incorporate non-animal dairy-equivalent proteins into their formulations.

Eden Brew called the milestone a major moment for its team, investors, and partners, and said the application would help pave the way for future precision-fermented proteins entering the ANZ market. “This is a huge moment for Eden Brew, and for the entire Australian precision-fermentation sector,” the company said, adding that it looked forward to the progression of the assessment over the coming year.

FSANZ’s review, and the subsequent consultation period, will determine whether BCPP1 is added to Schedule 26 as a permitted food produced using gene technology. If approved, it would mark the first regulatory clearance for a precision-fermented milk protein in Australia, setting an important precedent for companies developing next-generation functional nutrition ingredients.