What Is a Novel Food? Understanding FSANZ’s Criteria

FSANZ novel food criteria explainedBringing a new food ingredient to the Australian or New Zealand market? You need to know whether it qualifies as a novel food under Food Standards Australia New Zealand (FSANZ) regulations. If an ingredient is considered novel, it must go through a safety assessment before being sold. But what exactly makes an ingredient novel, and how can businesses stay compliant? 

In this guide, we’ll simplify the process and answer your biggest questions about FSANZ’s criteria and how to navigate approval. What exactly makes an ingredient a novel food? What steps do you need to take to stay compliant? Keep reading to find out. For official FSANZ guidelines, check out their novel food resource. 

What Is a Novel Food and Why Does it Matter? 

According to FSANZ, a novel food is any ingredient without a significant history of human consumption in Australia or New Zealand that requires a safety review before entering the market. This applies whether the ingredient is entirely new or has undergone processing that changes its safety profile. 

FSANZ’s Two Key Criteria

  1. Non-traditional food – The ingredient doesn’t have a well-documented history of consumption in Australia or New Zealand. 
  2. Requires a safety assessment – The ingredient may pose health risks, so FSANZ must evaluate it before approval. 

FSANZ offers guidance on how novel food status is determined. If you’re unsure about your ingredient, check their Advisory Committee on Novel Foods for expert recommendations. 

Examples of Novel Foods 

  • Exotic plant extracts (e.g., moringa or baobab powder) 
  • New protein sources (e.g., insect-based proteins) 
  • Lab-grown or engineered foods (e.g., cultivated meat) 
  • Fermented or bioengineered ingredients with altered compositions 

How to Get FSANZ Approval for a Novel Food 

If your ingredient meets the novel food criteria, it must go through FSANZ’s approval process. Here’s what to expect: 

1. Check If It’s Novel

Before anything else, research whether your ingredient has a consumption history in Australia or New Zealand. If you’re unsure, FSANZ provides a Novel Food Determination Tool to help assess whether further review is needed. 

2. Consult FSANZ’s Advisory Committee

Still uncertain? FSANZ’s Advisory Committee on Novel Foods (ACNF) can provide clarity on whether an ingredient requires approval. Their guidance page outlines the process for seeking recommendations. 

3. Submit an Application for Safety Assessment

If your ingredient is classified as novel, you’ll need to submit a pre-market safety assessment application to FSANZ. This includes: 

  • Ingredient composition 
  • How the ingredient will be used in food products 
  • Toxicology and safety research 
  • Consumer exposure data 

For a full breakdown of the application process, visit FSANZ’s Application Handbook. 

Why Compliance with FSANZ Matters 

Ignoring FSANZ regulations can lead to serious setbacks for your business. Failure to comply can result in legal penalties, costly product recalls, and significant delays in getting your product to market. Beyond the financial risks, non-compliance can damage your brand’s reputation and erode consumer trust, making it even harder to regain lost ground. 

Understanding FSANZ’s novel food requirements ensures you avoid these pitfalls. By following the right approval process from the start, you can streamline your product launch, minimize risks, and confidently bring new ingredients to the market without unexpected regulatory hurdles. 

Need Help Navigating FSANZ Regulations? 

Figuring out novel food regulations can be tricky, but you don’t have to do it alone. GRAS Experts specializes in regulatory compliance, helping businesses like yours get the approvals they need. 

Contact us today for expert guidance on FSANZ compliance and approval processes. You can also fill out our form for a complimentary consultation to discuss your specific needs. 

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Andrew Parshad

Andrew Parshad is President, CEO and founder of Quality Smart Solutions, a North American compliance solutions provider offering regulatory and quality assurance services to comply with FDA & Health Canada brands and ingredients regulations in the categories of dietary supplements, foods, cosmetics, OTC drugs and medical devices. Andrew started Quality Smart Solutions in 2007. Since that time he and his firm has served thousands of clients worldwide . Andrew's affiliate company, Quality IMPORT Solutions that offers import agent services into the Canadian market as a government licensed importer for foods, dietary supplements and medical devices.

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