Introducing a new food ingredient into the Australian or New Zealand market means working within a regulatory system that takes safety seriously. FSANZ reviews novel foods carefully, especially when they involve new production methods or have limited consumption history.
With the right preparation and a clear plan, you can move through the approval pathway more smoothly. Here is an overview to help you understand the main steps and what to expect if you are preparing a novel food submission.
Step 1: Confirm Whether Your Product Is a Novel Food
Before starting an application, you need to determine if your ingredient is classified as a novel food. FSANZ defines a novel food as one without a significant history of human consumption in Australia or New Zealand, or one that raises potential safety concerns because of its structure, production process, or composition.
If you are unsure how your ingredient will be classified, you can request informal clarification from the Advisory Committee on Novel Foods (ACNF). While this input is not legally binding, it can help you understand whether a full FSANZ application will be required and save considerable time at the beginning of your project.
Step 2: Prepare a Safety Assessment Package
A strong safety assessment is the foundation of your submission. FSANZ reviews a wide range of information to ensure the ingredient is safe for its intended use.
This usually involves the following: providing toxicological data, details about the nutritional composition, estimates of expected consumer exposure, information on potential allergenicity, production and purity details, and any relevant history of use in other markets.
The goal is to demonstrate that the novel food does not pose health risks when consumed as intended. Preparing thorough and well-organized documentation helps reduce follow-up questions from FSANZ and keeps your application moving.
Step 3: Compile Your FSANZ Novel Food Application
Once your safety data is complete, you can prepare your formal submission. This includes:
- a full scientific dossier
- detailed production information
- proposed food categories and intended uses
- supporting studies, including exposure assessments
- any international regulatory decisions that support your case
Accuracy is essential in this step. Incomplete or unclear dossiers often result in additional information requests, which can extend the review timeline.
If you work with new substances or developing ingredients, you may also benefit from reviewing regulatory requirements for other regions.
Step 4: Submit Your Application and Undergo FSANZ Review
After submitting your dossier, FSANZ conducts a structured review. This generally includes:
- a preliminary assessment
- a scientific risk assessment
- a public consultation period
- a final decision and publication
The full process can take several months. Being responsive to questions and ensuring your data is complete helps keep your application on track.
Once approved, the ingredient is added to the Australia New Zealand Food Standards Code and can be used in the food supply under the conditions set by FSANZ.
Step 5: Maintain Compliance After Approval
FSANZ approval is not the endpoint. After your ingredient is added to the Food Standards Code, you must continue to meet all regulatory expectations.
This includes keeping accurate records, updating labels as needed, and monitoring any new safety information that may affect your ingredient. It is also important to inform partners if there are changes in how the ingredient is produced or used.
Finally, staying aware of regulatory updates helps you address any new requirements in a timely way. Together, these ongoing steps help prevent compliance issues and ensure your ingredient remains suitable for the market.
Key Takeaways
- FSANZ approval is required for any food ingredient without a clear history of consumption in Australia or New Zealand.
- Early classification, including input from the ACNF, helps determine the right regulatory path.
- A complete safety package is essential and should include toxicology data, nutritional information, and exposure estimates.
- The FSANZ review process includes scientific evaluation and public consultation and may take several months.
- Post-approval compliance is ongoing. Companies must maintain records, monitor safety data, and ensure labelling continues to meet FSANZ requirements.
Top 5 FAQs About FSANZ Novel Food Approval
1. What does FSANZ consider a novel food?
A novel food is one without a significant history of human consumption in Australia or New Zealand, or one that may present safety concerns because of how it is produced or structured. Ingredients that use new technology or are highly modified often fall into this category.
2. Do I need to confirm novel food status before preparing an application?
Yes. Understanding whether your ingredient qualifies as a novel food is an important first step. You can review FSANZ criteria or seek informal feedback from the ACNF to clarify your pathway early.
3. What safety information does FSANZ expect?
FSANZ reviews toxicology data, nutritional details, consumption patterns, and allergenicity. These data points help determine whether the ingredient is safe for its intended use.
4. How long does the FSANZ review process take?
Timelines vary, but most applications take several months. The review includes a preliminary check, a scientific assessment, and a public consultation period.
5. Can I sell my novel food before FSANZ approval?
No. Novel foods must be approved and listed in the Food Standards Code before they can be used or sold in Australia or New Zealand.
Pathway to FSANZ Compliance
Bringing a novel food to the Australian or New Zealand market requires a clear plan and a full understanding of FSANZ expectations. By confirming classification early, preparing a complete safety package, and submitting a clear application, you can move through the approval pathway with greater confidence.
If you need support preparing your FSANZ submission, you can reach our regulatory team or learn more about our FSANZ novel food application services. We are here to guide you through each step of the process and help you get your ingredient market-ready.
