7. Importation Requirements

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Food Supplements
Australia

This section provides information on the importation process (shipment, customs, licenses required, and tests requirements).

7.1 Shipment Declaration

Biosecurity Act 2015

The Biosecurity Act 2015 [7] relates to diseases and pests that may cause harm to human, animal, or plant health or the environment. The Australian Department of Health oversees the aspects relating to human health (infectious diseases, pandemics, etc.), and the Department of Agriculture, Fisheries, and Forestry (DAFF) oversee all other aspects. Chapter 3 of the Act relates to goods that are brought into Australia via air or sea. Prior notice must be given that the goods are intended to arrive (Section 120 of the Act). The goods come under biosecurity control once they arrive in Australian territory. A biosecurity officer may inspect the goods and take samples (Section 125) and may ask for documentation. The goods remain under biosecurity control until released under Division 10 (Part 3, Chapter 1) of the Act or exported/destroyed. Section 176 briefly covers permit applications.

7.2 Customs Procedure

Customs Act 1901

The Customs Act 1901 [14] relates to customs law and border-related revenue. Part IV of the Act deals with the importation of goods. The Act is enforced by various departments, including the Australian Customs Service and the Australian Federal Police. Australian Border Force is responsible for customs clearance.

BICON (which is run by the Department of Agriculture, Fisheries, and Forestry [DAFF])

The Biosecurity Import Conditions Systems portal (BICON) [15] allows companies to determine the relevant conditions for the import of their goods. This includes whether the good requires an Import Permit. Other relevant conditions may include required import conditions, accompanying documentation requirements, and whether the good requires any treatments (sanitation, etc.). Even if an Import Permit is not required, there are usually these other requirements for import. This includes non-commodity requirements relating to the packing materials (i.e., pallets, outer packing containers, fumigation, etc.) and seasonal requirements in relation to pests such as Brown Marmorated Stink Bug.

Import conditions are decided under Cases. Users can search for the commodity they wish to import on the BICON portal (via the home page) and the system will suggest relevant Cases based on answers to questions. For example, searching on 'dietary supplement' yields the Case "Dietary supplements and natural medicines of plant origin for human consumption". Clicking on the link will then present a number of questions. If the user selects only plant-based ingredients, the final Case will show it does not require an Import Permit. If the user selects the option for other components (e.g. animal-derived ingredients), they are redirected to the case "Case: Human therapeutics and medicines" which would require an Import Permit.

Cases can be printed to provide a summary of all requirements. It is recommended that this be saved to substantiate the requirements during future imports since sometimes local customs brokers ask why there is no import permit. Users can follow a Case to be notified of any changes to the requirements (requires a user ID for the portal which can be obtained via the 'Register' option on the homepage). They can also apply for an import permit from the Case landing page. Once the user has access via a BICON account they can access online training resources which are very useful.

7.3 Manufacturing License

Licensing of manufacturing sites is assessed during the marketing authorization stage (refer to section "6. Registration processes"). For importation, a copy of the manufacturing site license may be requested for the Import permit applications.

7.4 Test for Importation

The analytical tests and release limits are usually set in line with the information described under sections "3. Compositional aspects" and "6. Registration processes". In some cases, the import documentation package may require a certificate of analysis. Any other special testing would be defined in the import requirements under the relevant Case. There are also occasions where additional tests or treatments are applied, usually in response to a biosecurity risk. For example, in the food area, there are restrictions in relation to White Spot Disease (in crustaceans). Another example is African Swine Fever, which requires certain goods using porcine materials (including trypsin) to undergo suitable treatment. Information on biosecurity risks is published on the DAFF page [5]. Should irradiation be required, DAFF has a list of approved offshore facilities [13].

7.5 Other Notes or Requirements for Importation

Importing Overview
Any finished medicine product being imported to Australia must have an Australian marketing authorization and must be entered into the Australian Register of Therapeutic Goods (ARTG) unless the medicine is exempt from ARTG entry under Section 18 of the Act [1] and Schedule 5 and 5A of the Regulations [2].

Some examples of exemptions are:

(a) samples for submission to the TGA, or for product development and quality testing (i.e., will not be supplied on the market), and clinical trial materials.

(b) personal imports (maximum 3-month supply for self or family member)

(d) some classes of goods (e.g. some homeopathic preparations, medicated shampoos, sunscreens). Note: this is generally not relevant to most Dietary Supplement type products.

(e) starting materials for the manufacture of medicine, except when in a medicine dose form.

(There are other exemptions for commercial reasons as outlined in Schedule 5 and 5A of the Regulations).

For both ingredient and finished product importation:

Importation includes both Customs and Quarantine procedures. Some medicines and/or ingredients may require an import permit, import declaration, and other documentation, depending upon the nature of the origin of the ingredients (e.g. plant, animal, or synthetic). The rules for medicines and ingredients are often the same since the need for permits is based on the components and not the finished medicine.

Import Permit Applications

Import Permit applications are submitted via the BICON portal (see C20 for details). The current costs are AU $120 for the application fee and then a charge of between AU$ 60 to $480, depending upon the category. Information on charges is available on the DAFF website [6]. Permits can be used for multiple shipments and expire after two years. While DAFF advises an expected approval time of 20 working days for a permit this is often exceeded. Applicants should apply early and can have a permit commence immediately after it is approved or from a set date. This way a permit renewal application can be made up to six months early to commence when the old permit lapses.

Multiple finished products (including multiple pack sizes) can be covered by the same permit, provided the ingredients that require the permit are the same. If goods arrive without a permit, they are either destroyed or exported (the importer pays the costs) and there is no option to apply for an import permit retrospectively. There are provisions under section 186 of the Biosecurity Act [7] for fines and imprisonment for offenses relating to importation without a valid import permit.

Import Documentation

Typically, the documentation package would include a commercial invoice, packing list, and packing declaration (sea freight only, this is a list of the physical packaging materials used. Some countries use restricted materials such as hay, chaff, straw, and bamboo), fumigation certificate (as required for pallets, etc.), certificate of origin (assists with customs' fees reduction where Australia has a Free Trade Agreement), and likely a Phytosanitary certificate. Copies of all required documents should accompany the goods to facilitate the release of the goods. Any missing documents will lead to delays in the clearance of the goods, which may incur holding fees at the customs/quarantine bond facility. [8]

DAFF has information and FAQs on the minimum documentation requirements on its website [8] and documentation templates [9], the use of which is optional.

Import Fees

Fees apply for inspections of imported goods, on a cost-recovery basis. The DAFF website provides a link to its cost policy and fee structure [10]. Customs charges also apply and are commercially calculated on a number of factors. There is an online guide [11] on calculating fees and excises. Some of these are reduced or waived if there is a Free Trade Agreement between the exporting country and Australia, which is why an accurate certificate of origin is important. A list of current Free Trade Agreements is available on the Austrade website [12].