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Exporting food supplements from Australia

Where a supplement is a therapeutic good in Australia, the Therapeutic Goods Act 1989 makes exporting it for use in humans an offence if it is not registered, listed or exempt and could cause harm. A medicine made only for export can be an export only medicine. Fish oil or milk capsules sit mostly outside the Export Control Rules.

Updated · Each section links to the official source it comes from

Therapeutic goods
Therapeutic Goods Act 1989, which reaches export as well as supply
Export only medicines
Made or imported only for export, and listable for that reason
Sponsor duty
Manufacturer and premises notified before export
Capsules and tablets
Fish and milk products in tablet or capsule form are generally not prescribed goods
Organic claims
Organic goods certificate under the Export Control (Organic Goods) Rules 2021
Customs
Export declaration for most goods over A$2,000

Before the goods leave

The questions to answer, in the order they usually come up.

  1. 1Is the supplement a therapeutic good in Australia, or a food? Read more
  2. 2Is it registered or listed, or an export only medicine, and are its manufacturer and premises notified? Read more
  3. 3Is it a fish, milk or egg product that an importing country requires certified under the Export Control Act? Read more
  4. 4Does the label claim organic or biodynamic? Read more
  5. 5Does it need an export declaration, and will the buyer claim an FTA tariff? Read more

The rules, by area

What each area covers, the texts that set it, and what the official pages say.

Therapeutic goods on export

Where a supplement is a therapeutic good, the Therapeutic Goods Act 1989 reaches its export as well as its supply in Australia.

  • The TGA says most supplements in Australia are complementary medicines entered on the Australian Register of Therapeutic Goods, and that medicines made solely for export must also be listed.
  • A person commits an offence if they export from Australia therapeutic goods for use in humans that are not registered or listed in relation to them, exempt, or covered by an approval or authority, and the goods' use is likely to cause harm or injury (section 19B).
  • An export only medicine is a medicine manufactured in Australia, or imported into Australia, for export only, and listable goods only because it is so manufactured or imported.
  • A sponsor who exports therapeutic goods for use in humans commits an offence, and can be liable to a civil penalty, if the manufacturer and the premises used in manufacture have not been properly notified to the Secretary (sections 20 and 20A).
  • Exporting goods that do not conform to an applicable standard, other than a standard on labelling for supply in Australia, without the Secretary's written consent is an offence where harm is likely (section 14).

How we help: Compliant Always keeps the entry in the Australian Register of Therapeutic Goods, the manufacturer and premises details and the product's standards evidence with each export lot, dated. Ask about this

Export Control Rules for capsules and organic claims

Where agricultural export controls reach supplement ingredients.

  • Fish or fish products in the form of a tablet or capsule are not prescribed goods unless one or more requirements of the Export Control Act 2020 must be met to satisfy an importing country requirement.
  • The same applies to milk or milk products, and egg products, in the form of a tablet or capsule, and to fish or milk products that are pharmaceutical material.
  • Goods described as, or as including ingredients that are, organic, biodynamic or similar are prescribed organic goods; the exporter holds an organic goods certificate in force at export.
  • A government certificate may be issued for non-prescribed goods that are to be, or have been, exported, where Rules provide for it.

How we help: Compliant Always records whether each product is caught by the Export Control Rules for its destination, and keeps the organic goods certificate with the shipment. Ask about this

Export declaration and origin

Entering supplements for export, and proving origin for preferential tariffs.

  • An export declaration is needed for goods over A$2,000, for goods that need an export permit whatever their value, and for duty drawback claims.
  • If information in the declaration identifies a permission for the export, that is taken as producing the permission to an officer.
  • Exporters and producers who claim Australian origin for a preferential tariff keep origin records; for Japan, for at least five years from the certificate of origin.

How we help: Compliant Always keeps the declaration and the origin records behind each shipment, and answers an importer's origin questions from the record. Ask about this

Who answers for what

WhoWhat they answer forHow we help
SponsorRegistration or listing, notifying the manufacturer and premises, and exports of the goods.The Register entry and manufacturer details kept with each export lot.
ManufacturerMaking the goods to the applicable standards, at notified premises.Batch records and specifications ready when an importer asks.
ExporterThe export declaration, certificates and origin claims.Certificates and origin records kept with the shipment, dated.

Ports and certifying bodies

Export controls on food, plants and organic goods are Commonwealth law under the Export Control Act 2020, administered by the Department of Agriculture, Fisheries and Forestry, with registered establishments and accredited properties across the states and territories.

Export declarations go to the Australian Border Force through the Integrated Cargo System, or at an ABF counter in each state or territory.

Where are the goods going?

Most of what food supplements have to meet is set where they are sold. Each guide sets out the rules on arrival, with the official source for each.

Questions businesses ask

Do I need TGA approval to export supplements from Australia?
If the supplement is a therapeutic good for use in humans, exporting it when it is not registered, listed, exempt or otherwise authorised is an offence where its use is likely to cause harm (section 19B, Therapeutic Goods Act 1989).
What is an export only medicine?
A medicine manufactured in Australia, or imported into Australia, for export only, which is listable goods only because it is so manufactured or imported.
Can I export a listed medicine made in Australia?
Section 19B does not catch goods listed in relation to the person exporting them. The sponsor must have properly notified the manufacturer and manufacturing premises to the Secretary before the export (sections 20 and 20A).
Does a supplement exported from Australia have to carry an Australian label?
The export offence in section 14 for goods not conforming to a standard excludes standards relating to labelling for supply in Australia. Destination labelling rules are in the market guides.
Do fish oil capsules need an export permit from Australia?
Fish products in tablet or capsule form are not prescribed goods under the Fish Rules unless a requirement of the Export Control Act 2020 must be met to satisfy the importing country.
Do milk powder or colostrum tablets need an export permit?
Milk products in tablet or capsule form, colostrum and milk products from animals other than cattle are not prescribed under the Milk Rules unless an importing country requirement must be met through the Act.
How do I export organic supplements from Australia?
Goods described as organic, biodynamic or similar, or as including organic ingredients, are prescribed organic goods. The exporter needs an organic goods certificate in force when the goods are exported.
Do I need an export declaration for supplements?
For consignments worth more than A$2,000, for goods that need an export permit, and for duty drawback claims. Smaller consignments are generally exempt.
Can I claim back import duty on ingredients used in exported supplements?
The ABF's duty drawback scheme refunds customs duty on imported goods that are exported unused or after being processed or incorporated into goods for export, claimed within four years of export.
Do supplements made only for export from Australia need TGA listing?
Yes. The TGA says medicines made solely for export must also be listed on the Australian Register of Therapeutic Goods. Most supplements in Australia are listed complementary medicines, each with an AUST L number.
How does Compliant Always help with exporting from Australia?
Our team reads the rules for the routes you ship. Compliant Always shows which export documents apply to your product, keeps them with the shipment beside what the destination asks for, and watches the sources for changes. It shows what the requirements say and what your documents show; you decide.

Sources

Compliant Always is a product of Lettuce Labs LLC. It shows what requirements say and what your documents show. It is not legal advice, and you decide.

Tell us what you make, and we will show you the rules for it.

Name the product and the markets you sell in. We will come back to you with what applies in Australia and what your paperwork needs to show.

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