If you are preparing to launch a new ingredient or food product in Australia or New Zealand, one of the first regulatory questions you need to answer is whether the product may be considered novel. This determination has direct implications for compliance, approval timelines, and whether your product can legally enter the market.
Many businesses assume that an ingredient already sold in other regions will automatically be accepted locally. However, Food Standards Australia New Zealand applies its own criteria, and products that are familiar elsewhere may still require review. Understanding how FSANZ approaches novelty early can help you avoid delays, reformulation, or enforcement action later on.
What FSANZ Means by a Novel Food
FSANZ defines a novel food as a food or ingredient that does not have a history of safe human consumption in Australia or New Zealand. When that history cannot be clearly demonstrated, a pre-market safety assessment is required before the product can be sold.
This assessment focuses on local consumption patterns rather than global availability. An ingredient may be widely used overseas and still be considered novel if there is limited evidence that it has been consumed safely in Australia or New Zealand. Processing methods, changes in composition, and intended use are also taken into account.
In practical terms, novelty is not about whether a product is innovative or trendy. It is about whether sufficient evidence exists to support its safe consumption in these specific markets.
How FSANZ Assesses Novel Food Status
When FSANZ evaluates whether a product falls under novel food requirements, it considers two factors together.
The first is whether the food is non-traditional. This generally means there is no established pattern of consumption in Australia or New Zealand prior to May 1997, or that evidence of use is limited or unclear.
The second factor is whether the food requires a safety assessment. Even when some consumption history exists, changes in how the food is produced or used can alter its safety profile. Higher concentrations, new manufacturing processes, or different exposure levels can all trigger regulatory review.
Because these factors are assessed on a case-by-case basis, determining whether an ingredient qualifies as a FSANZ novel food often requires a detailed review of available evidence.
Foods That Commonly Raise Novelty Questions
Novel food assessments frequently apply to ingredients that fall outside traditional supply chains. This includes certain botanical extracts, alternative protein sources, and foods produced using newer technologies.
In some cases, even familiar foods may be considered novel if they are consumed in a new form or at levels that significantly increase dietary exposure. These nuances are easy to overlook, which is why early assessment is critical.
Assuming that an ingredient is acceptable without reviewing how FSANZ is likely to interpret its use can create unnecessary regulatory risk.
Why Compliance With FSANZ Matters
Compliance with FSANZ novel food requirements is mandatory under the Australia New Zealand Food Standards Code. Foods that are classified as novel cannot be sold unless they have been specifically approved following a safety assessment.
Non-compliance can result in enforcement action, product recalls, and delays that affect commercial relationships. Beyond regulatory consequences, failing to meet these requirements can damage credibility with retailers and consumers.
Confirming whether your product meets the criteria for a FSANZ novel food before launch helps protect both your investment and your brand.
What the FSANZ Approval Process Involves
If a product is determined to be novel, a formal pre-market application must be submitted to FSANZ. This application must demonstrate that the food is safe for its intended use.
Submissions typically include information on composition, manufacturing methods, dietary exposure, and toxicological data. FSANZ reviews the evidence and may request additional clarification before making a decision.
While the process is clearly defined, applications often face delays when data is incomplete or does not align with FSANZ expectations. Planning ahead and understanding the requirements can make a significant difference.
How FSANZ Fits Within a Global Regulatory Strategy
Although FSANZ has its own regulatory framework, its safety principles are consistent with approaches used by other authorities. For example, the U.S. Food and Drug Administration evaluates food safety using scientific evidence and exposure assessments when determining whether an ingredient can be marketed. Reviewing FDA guidance can support a broader compliance strategy, but it does not replace the need to meet FSANZ requirements.
For businesses operating across multiple markets, understanding these differences helps avoid assumptions that could slow down approvals.
Key Takeaways
- Novel food status is based on local consumption history, not global use
- Natural or familiar ingredients may still require assessment
- Early review helps avoid delays and compliance issues
- Approval is required before novel foods can be sold
- Regulatory guidance can reduce uncertainty and risk
Frequently Asked Questions
Does being classified as a novel food mean the product is unsafe?
No. A novel food classification does not automatically mean a product is unsafe. It simply indicates that FSANZ does not have enough evidence of safe consumption in Australia or New Zealand to make a determination without a formal review. Many ingredients are classified as novel because they are new to the local market, not because they present a known risk. With the right scientific data, many novel foods are approved and sold legally.
Can I sell or import my product while FSANZ is reviewing my application?
No. If your ingredient requires approval, it cannot be sold, imported, or supplied for retail sale until FSANZ has completed its assessment and the ingredient is permitted under the Food Standards Code. Launching early can lead to enforcement action, recalls, and issues with retailers or distributors.
How long does it usually take to obtain FSANZ approval for a novel food?
There is no fixed timeline. The review period depends on the complexity of the ingredient, how it will be used in food, and whether the submitted data clearly addresses safety concerns. Applications may take longer if FSANZ requests additional information or clarification. Starting the assessment early, ideally during product development, helps avoid unexpected delays close to launch.
If my ingredient is approved in other countries, do I still need FSANZ approval?
Often, yes. FSANZ focuses on consumption history and exposure in Australia and New Zealand. While approvals from other regulators can strengthen your safety case and support your submission, they do not replace FSANZ requirements. Each application is assessed based on local use conditions and dietary exposure.
What are the risks of assuming my product is not novel?
If a product is later determined to meet the criteria for a novel food, it may need to be withdrawn from the market until approval is granted. This can result in lost sales, product recalls, contractual issues with partners, and reputational damage. A proper assessment upfront provides clarity and reduces regulatory and commercial risk.
Support With Novel Food Assessments
Determining whether your ingredient qualifies as a FSANZ novel food and preparing the necessary documentation can be complex, particularly when timelines and investment decisions are involved. Working with regulatory specialists can help you assess risk early and plan a compliant path to market.
If you need support reviewing your product or preparing a submission, our team can help you navigate FSANZ requirements and move forward with confidence.
