What’s next for Vow on the path to regulatory approval in Australia?

Written by Jessica Freitag

December 11 2023

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Australian cellular agriculture company, Vow was the first company to commence the regulatory approval process for their cultured quail product earlier this year. 

As the first cultivated meat application to be accepted by Food Standards Australia and New Zealand (FSANZ), the process has been uncharted territory for Vow and FSANZ.

So, you might be wondering - what has happened since, and what’s next for Vow?

First, let’s briefly look at the role of FSANZ, and the regulatory approval process.

FSANZ develops and amends food standards published in the Australia New Zealand Food Standards Code (‘the Code’) in accordance with specific objectives and procedures set out in the FSANZ Act. Importantly, all food sold in Australia and New Zealand must comply with the Code. However, only certain foods, including those considered novel such as cultivated meat require formal approval through a pre-market safety assessment.

As such, Vow has sought regulatory approval through a pre-market safety assessment of its cultured quail product as a novel food ingredient, which relates to Standard 1.5.1 of the Code.

So, what exactly is novel food?

Like the name suggests, novel foods are new or non-traditional foods or substances derived from foods that align with the following criteria:

• A food that does not have a history of human consumption in Australia or New Zealand;
• Or a substance derived from a food, where that substance does not have a history of human consumption in Australia or New Zealand other than as a component of that food;
• Or any other substance, where that substance, or the source from which it is derived, does not have a history of human consumption as a food in Australia or New Zealand. 

Vow’s successful submission to FSANZ is a major achievement in itself! A significant amount of work has gone into producing and having the application accepted, meaning FSANZ is satisfied that it meets the high-level requirements set out in the Application Handbook.

Vow’s application has since undergone a formal assessment process. Their application is considered a ‘major procedure’ (as opposed to a ‘general procedure’), which is based on the time estimated to complete the assessment. Major procedures are generally undertaken when FSANZ deems the application as requiring significant scientific or technical assessment, and a higher degree of public consultation.

This is unsurprising given it is the first of its kind - but something we hope to see change over time when the approval process for cultivated foods becomes further clarified and ideally, is no-longer considered novel.

The assessment commenced in late February, and has included chem​ical, nutritional, microbiological and dietary exposure assessments, a detailed examination of the applicant's production process and a review of the food science to ensure that the product is safe to consume prior to it going on sale. 

Now that FSANZ have completed their scientific risk assessment, Vow’s application has commenced the public consultation period, which is expected to run until  February 2024.

FSANZ’s work is open for public scrutiny, which is why public consultation is an essential part of the approval process. FSANZ publicly consults on all applications that involve changes to the Code, and involves FSANZ publishing a call for submissions that details their assessment and whether they intend to propose approving the application.

Vow’s assessment process will involve two calls for submissions, with comments typically received from government enforcement agencies, industry associations, industry, public health bodies and the public. Submissions will need to focus on the efficacy of the food safety claims and the science underpinning the product, and any implications for amending the Code.

We will be producing a Submission Guide to help all stakeholders make coordinated and consistent submissions in support of Vow’s application.

You can make a submission through the FSANZ Consultation Hub. All non-confidential submissions will be posted on FSANZ’s website, and the issues raised will be evaluated and addressed in their assessment report. 

Assuming that FSANZ intends to approve Vow’s cultured quail for sale in Australia, FSANZ will then propose an amendment to the Code and prepare a draft food regulation measure. 

Following this, there will be the opportunity for further public comment. And finally, the application must receive FSANZ board approval, after which the Food Minister’s Meeting will be notified and the approval finalised.

If all goes well and no review is requested, Vow’s cultivated quail should receive final approval in late 2024.

You find out more and read a redacted version of Vow’s application to FSANZ here.

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