Case Glossary

Biological excipients are highly processed substances that are components of commercially packaged human therapeutic products, laboratory materials or food products. The following substance groups are considered excipients for human therapeutic products, laboratory materials or products intended for human consumption only and are excipients only when ready for retail sale without any further processing:

1. Alcohols
   

2. Citric acid
   

3. Cultures of Saccharomyces cerevisiae (or a derivative of a pure culture of Saccharomyces cerevisiae)
   

4. Essential oils
   

5. Esters
   

6. Fish oil (other than salmon oil)
   

7. Gelatine
   

8. Glucosamine, chondroitin or chitosan of aquatic animal origin (except if derived from fish of the family Salmonidae or intended for veterinary therapeutic use in aquatic animals)
   

9. Highly processed biochemicals derived from wool grease (including cholesterol, cholecalciferol vitamin D3, lanolin and lanolin alcohols)
   

10. Homeopathic preparations
    

11. Lactic acid
    

12. Lactose
    

13. Natural flavourings
    

14. Pectins
    

15. Plant acids
    

16. Plant extracts (other than flours or powders)
    

17. Plant gums
    

18. Plant juices
    

19. Plant oils
    

20. Plant waxes
    

21. Purified amino acids (other than those derived from neural material)
    

22. Purified antibiotics or antimycotics manufactured without using materials of terrestrial animal or avian origin (except if intended for veterinary therapeutic use in aquatic animals)
    

23. Purified avermectin compounds manufactured without using materials of terrestrial animal or avian origin (except if intended for veterinary therapeutic use in aquatic animals)
    

24. Purified corticosteroid manufactured without using materials of terrestrial animal or avian origin
    

25. Purified milbemycin compounds manufactured without using materials of terrestrial animal or avian origin (except if intended for veterinary therapeutic use in aquatic animals)
    

26. Resins
    

27. Starches
    

28. Sugars
    

29. Tinctures
    

30. Vinegars
    

31. Vitamins or provitamins
    

32. Water
    

33. Xanthan gum
    

Biological material means any material originating from an animal, plant, microorganism or microbial source, but does not include human material.

The carrier is what the starter culture is in or on and helps facilitate its handling. The carrier is therefore a substance used to dissolve, dilute, disperse or otherwise physically modify the culture, enabling its application or use. The carrier does not alter the culture’s function and does not exert any effect. Examples: the starter culture Lactobacillus caseii can be in the carrier milk (bovine dairy), or the starter culture Bacillus subtilis can be on a corn cob carrier.

Goods include:

1. An animal.

2. A plant.

3. Any other article, substance or thing (including, but not limited to, any kind of moveable property); and, to avoid doubt, includes mail of any kind and ballast water.

Therapeutic use means use in or in connection with:

(a) preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons; or

(b) influencing, inhibiting or modifying a physiological process in persons; or

(c) testing the susceptibility of persons to a disease or ailment; or

(d) influencing, controlling or preventing conception in persons; or

(e) testing for pregnancy in persons; or

(f) the replacement or modification of parts of the anatomy in persons.

Human tissue does not include:

(a) a deceased human’s body, or part of a deceased human’s body, that is being brought or imported into Australian territory for burial or cremation; or

(b) hair, teeth or bones from a human’s body, if without adhering tissue.

The department will assess the application and on the basis of that assessment may decide to grant an import permit subject to any conditions deemed necessary for safe importation, use and disposal of those products.

It should be noted that applying for an import permit does not automatically result in an import permit being issued. The Director of biosecurity or their delegate issues the import permit. You should ensure that an application is submitted for each product type and that the prescribed fee accompanies the import permit application.

The Imported Food Control legislation does not apply to food that has been taken to be imported for private consumption:

1. Up to 10 kilograms of solid food, or
   

2. Up to 10 litres of liquid food, or
   

3. Up to 2 litres of concentrated liquid food, or
   

4. Up to 2 kilograms of dried food, or
   

5. Up to 1 kilogram of spices