Introduction
If you’re planning to introduce a novel food product in Australia or New Zealand, you must first obtain approval from Food Standards Australia New Zealand (FSANZ). The process to get your Novel Food Approved by FSANZ ensures that all new food products meet safety standards before reaching consumers.
Navigating FSANZ regulations can be complex, but breaking it down into clear steps simplifies the process. Below, we outline the five key steps to getting your Novel Food Approved by FSANZ, helping you stay compliant and bring your product to market successfully.
Step 1: Determine If Your Product Requires FSANZ Approval
Before applying, you must confirm whether your product is considered a novel food under FSANZ standards. A novel food is one that has no significant history of human consumption in Australia and New Zealand or requires assessment due to potential safety concerns.
FSANZ provides guidelines to help determine whether your product qualifies as novel. Refer to FSANZ guidelines for classification criteria.
Step 2: Conduct a Safety Assessment for FSANZ Approval
FSANZ requires a detailed safety assessment to evaluate potential health risks. This includes toxicological data to ensure the food is safe for consumption, nutritional information to assess any significant impact on the diet, and an analysis of consumption patterns to understand how the food will be used by consumers.
Ensuring thorough documentation at this stage is crucial for a smooth approval process.
Step 3: Prepare Your FSANZ Novel Food Application
Once you’ve completed the safety assessment, you must compile a formal FSANZ application, which includes:
- A scientific dossier with evidence supporting the safety of your product.
- Proposed food category and conditions of use.
- Supporting studies, including toxicology and dietary exposure data.
Accuracy and completeness in this step can prevent delays and additional requests for information from FSANZ.
Step 4: Submit Your Application and Undergo FSANZ Review
After submission, FSANZ conducts a rigorous review, which typically follows these stages:
- Preliminary assessment – Determines if the application meets basic requirements.
- Public consultation – Allows stakeholders to provide feedback.
- Risk assessment – Evaluates health and safety data.
- Approval and notification – If all criteria are met, FSANZ publishes the approval.
This process can take several months, so early submission and responsiveness to FSANZ queries can help expedite approval.
Step 5: Maintain Compliance After FSANZ Approval
Once approved, your novel food is added to the FSANZ Food Standards Code, and you can begin distribution. Ensure ongoing compliance by:
- Monitoring labeling and advertising for regulatory adherence.
- Keeping updated safety records to address future audits.
- Staying informed on regulatory changes that may affect your product.
Final Steps to Approval
Securing FSANZ approval for novel foods requires strategic planning, thorough documentation, and adherence to regulatory standards. By following these five steps, you can navigate the approval process with confidence and bring your innovative food product to market in Australia and New Zealand.
Want to fast-track your FSANZ approval? Talk to GRAS Experts today or fill out the form below to get expert support at every step!
