Bringing a new substance or novel food to market in Australia or New Zealand requires meeting strict regulatory standards. GRAS Experts provides comprehensive support for Therapeutic Goods Administration (TGA) new substance applications in Australia and Food Standards Australia New Zealand (FSANZ) novel food applications in both Australia and New Zealand.
If you’re introducing a new food ingredient, functional compound, or therapeutic substance, securing regulatory approval is essential. Our experts simplify the process, ensuring compliance with TGA (Australia) and FSANZ (Australia & New Zealand).
Regulatory approval for new substances used in therapeutic goods.
Comprehensive safety, toxicology, and scientific data compilation.
Market approval for novel food ingredients.
End-to-end submission support and agency follow-ups.
Identify classification requirements and regulatory pathways.
The Therapeutic Goods Administration (TGA) regulates new substances used in therapeutic goods in Australia. Applications are categorized into four levels based on the type of data available and the extent of evaluation required.
| Application Type | Scope | Requirements | Evaluation Timeframe (Working Days) |
| IN1 | Existing safety & quality evaluations from Comparable Overseas Bodies (COBs) | Submission of unredacted COB evaluation reports | 70 + 40 (preliminary assessment) |
| IN2 | COB safety evaluations; TGA evaluates quality data | COB safety reports and comprehensive quality data | 120 + 40 (preliminary assessment) |
| IN3 | COB quality evaluations or recognized monographs; TGA evaluates safety data | COB quality reports or relevant monographs with comprehensive safety data | 150 + 40 (preliminary assessment) |
| IN4 | Full de novo evaluation of safety & quality by TGA | Complete safety and quality data packages | 180 + 40 (preliminary assessment) |
Not sure which category applies to your ingredient? Our experts can assess your data and guide you through the right pathway.
We provide full support to ensure compliance with regulatory requirements, including:
Regulatory pathway and commercial considerations, such as importation, biosecurity, and market access.
Preparing toxicology, efficacy, and risk assessment reports.
Managing documentation, agency interactions, and regulatory responses.
A novel food is any food or ingredient without a history of use in Australia and requires assessment by Food Standards Australia New Zealand (FSANZ) to establish its safety before being sold as a food or used in food products. Our services cover:
Assess if your ingredient qualifies as novel.
Compile supporting safety and toxicology data.
Handle FSANZ documentation, progress tracking, and responses.
Assistance with submissions to FSANZ’s Advisory Committee on Novel Foods for a preliminary, non-binding assessment.
A TGA new substance application is required for any new ingredient used in therapeutic goods in Australia. It involves submitting scientific, safety, and efficacy data to meet regulatory requirements.
A novel food is any food or ingredient that does not have a history of significant consumption in Australia or New Zealand. FSANZ assesses novel foods to ensure they are safe before being sold or used in food products. If you are unsure about your ingredient’s status, we can help with determining its classification.
A FSANZ novel food application requires scientific research, toxicology reports, and safety assessments to demonstrate its suitability for human consumption.
Timelines vary based on the complexity of the application. TGA new substance approvals can take several months, while FSANZ novel food applications typically take between 12 to 24 months for completion.
Yes, we provide end-to-end regulatory support, from determining classification to dossier preparation, submission, and follow-up with regulatory authorities.
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