New ingredient applications: TGA, FSANZ and AICIS

Mapped at the brief

The approval route decides the timeline and the budget, so we settle it before the formula is locked. The pathway comes first (medicine, food or cosmetic?): the same ingredient can need a TGA application in a capsule, an FSANZ application in a food and an AICIS categorisation in a cream. Then the evidence: a new ingredient's safety and quality case, built so the application and the product's claims draw on the same work.

A listed medicine: the TGA's Permissible Ingredients Determination

A listed medicine, AUST L or AUST L(A), can only contain ingredients in the Permissible Ingredients Determination. A new substance needs an application to the TGA, and so does a new role or a change to an ingredient's requirements, such as a higher permitted level.

• Four levels, IN1 to IN4. The more of the safety and quality case that rests on an evaluation by a comparable overseas regulator, or on a published monograph, the less the TGA evaluates itself and the shorter the timeframe.
• Fees in 2026–27: $19,826 for an IN1 or IN2 application and $33,696 for IN3 or IN4.
• Timeframes: 40 working days for a preliminary assessment, then 70 to 180 working days for the evaluation, not counting time the clock is stopped.
• Exclusivity: a successful applicant for a new ingredient can opt in, when it applies, to two years of exclusive use.

The full process is in our permissible ingredients guide.

A food: an FSANZ novel food application

A novel food is a non-traditional food, one without a history of human consumption in Australia or New Zealand, that needs an assessment of its public health and safety. A food for retail sale can't be or contain one unless Schedule 25 of the Food Standards Code lists it, used within its conditions.

• The application asks FSANZ to change the Code, with a pre-market safety assessment.
• Fees: none unless the applicant stands to gain an exclusive commercial benefit, as when it asks for exclusive use, or pays to start sooner. An unpaid application waits about 12 months for its assessment to start. A paid one costs from $49,627 for the smallest general procedure to $137,767 or more for a major one.
• Timeframes: counted from the start of the assessment, FSANZ's Board decides within 9 months under the general procedure or 12 under the major one, then the Food Ministers have 60 days.
• Exclusivity: up to 15 months of exclusive use after gazettal, tied to the brand, though FSANZ can still approve the same food for others in that time.

The full process is in our novel foods guide.

A cosmetic: an AICIS introduction

AICIS regulates the industrial chemicals in cosmetics. Each ingredient is checked against the Australian Inventory of Industrial Chemicals, and each introduction is categorised: listed, exempted, reported or assessed. A reported introduction needs a once-off report before it starts, and an assessed one needs an assessment certificate from AICIS before the chemical is introduced: in 2026–27, applying for one costs from $14,530. The business introducing it also registers with AICIS. More in our AICIS registration guide.