This guideline clarifies the circumstances in which selenium products used in sheep do or do not require registration. It should be read in conjunction with the Australian Pesticides and Veterinary Medicines Authority's (APVMA) user guide: what is or isn’t a veterinary product.
Definition of a veterinary chemical product
The Agvet Code states that a veterinary chemical product includes a vitamin, a mineral substance or an additive, if (and only if) the vitamin, substance or additive is used for any of the following purposes:
- Preventing, diagnosing, curing or alleviating a disease or condition in the animal or an infestation of the animal by a pest
- During or alleviating an injury suffered by the animal
- Modifying the physiology of the animal to alter its natural development, productivity, quality or reproductive capacity or to make it more manageable
- Modifying the effect of another veterinary chemical product
According to this definition, a selenium product with a label that makes none of these claims is not a veterinary chemical product and does not require registration.
However, selenium and selenium salts are also approved active constituents. At certain concentrations, selenium and selenium salts are used for the prevention or therapy of diseases such as white muscle disease in cattle and sheep and for dermatological conditions in companion animals.
Which selenium products for sheep generally do and do not require registration?
|Therapeutic product claims?||Route of administration||Level of selenium||Dose of selenium||Registration required?||Label advisory statement|
|YES||Any route||Any level||The APVMA will assess the safety and effectiveness of the label-recommended dose||YES||To be decided during registration|
|NO||Oral dosage forms administered in animal feed||Levels such that the product does not fall into S4 or S7 of the SUSMP||Any dose less than, or equal to, 0.1 mg/kg Se BW1||NO||Refer to the Label advisory statement below|
|NO||Oral dosage forms administered in animal feed||Levels such that the product does not fall into S4 or S7 of the SUSMP||Any dose greater than 0.1 mg/kg Se BW1||YES||Refer to the Label advisory statement below|
||Any level||The APVMA will assess the safety and effectiveness of the label-recommended dose||YES||To be decided during registration|
|NO||Any route||Levels such that the product falls into S4 or S7 of the SUSMP||The APVMA will assess the safety and effectiveness of the label-recommended dose||YES||To be decided during registration|
SUSMP = Standard for the Uniform Scheduling of Medicines and Poisons
1Feeding Standards for Australian Livestock Ruminants, Standing Committee on Agriculture and Resource Management, CSIRO Australia, 1990, p 168.
Label advisory statement
Even if the selenium product need not be registered, we strongly advise manufacturers to include a warning on the product label that care should be taken to avoid oversupplementing with selenium. The use of selenium pellets and treatment of the pasture at the same time can lead to excessive selenium levels in tissues of sheep. You should also consult a veterinarian or adviser to ascertain the animals’ selenium status. The product should not be used in areas of seleniferous plants or soils in Queensland before a veterinarian has ascertained the selenium status.
The following warning statement on the product is recommended:
Excessive tissue levels of selenium are toxic. Care should be taken to avoid over-supplementation from this product and/or concurrent use of other products containing selenium (such as pasture top dressing, pellets, drenches or vaccine containing selenium). If blood selenium levels are high, this product should not be used. The user can determine an animal’s selenium status by consulting their veterinarian.