Operational Notice - Sperm and Ova Products
March 2004
Sperm and ova are defined in the Agricultural and Veterinary Chemicals Code Act 1994 (Agvet Code) as (microscopic) 'animals'. For the purpose of this policy ova are defined to include fertilized ova and microscopic embryos.
Sperm and ova products are used to dilute, nourish and protect sperm and ova collected for artificial insemination (AI), ovum transfer (OT), in-vitro fertilization (IVF) and embryo transfer (ET). They usually contain glucose and electrolytes, and may also contain antibiotics, albumins, amino acids or other metabolites, as well as buffers and stabilisers.
These products may be 'administered' to sperm and ova in the media used to wash dilute, store and prepare the sperm and ova for insemination or transplant. They are included for nourishment, protection or capacitation of the sperm or ova. The actual products 'administered' will vary depending on the expected time lapse between collection and insemination/transplant. Most formulations attempt to nourish, protect or capacitate the sperm or ova by mimicking the normal physical/physiological environment of the uterus.
The question arises whether a sperm and ova product meets the definition a veterinary chemical product for the purposes of the Agvet Code and therefore requires registration. In accordance with the Agvet Code, all veterinary chemical products, unless specifically exempted by the Regulations, must be registered before they can be supplied, distributed or sold anywhere in Australia.
Section 5(2) of the Agvet Code states that a veterinary chemical product is a substance or mixture of substances that is represented as being suitable for, or is manufactured, supplied or used for administration or application to an animal by any means, or consumption by an animal, as a way of directly or indirectly:
- preventing, diagnosing, curing or alleviating a disease or condition in the animal or an infestation of the animal by a pest; or
- curing or alleviating an injury suffered by the animal; or
- modifying the physiology of the animal so as to alter its natural development, productivity, quality or reproductive capacity or so as to make it more manageable; or
- modifying the effect of another veterinary chemical product.
Common ingredients used in sperm and ova products:
Antibiotics
Antibiotics are often included in sperm and ova products. Where antibiotics are included to enable sperm or ova product to prevent (or reduce the risk of) an infection by a micro-organism, the sperm and ova products would be considered to be veterinary chemical products. However, where antibiotics are included to maintain the quality of the product by preventing consumption of nutrients and consequent production of metabolic waste, the sperm and ova products would not be considered to be veterinary chemical substances. Cell culture media typically include antibiotics at levels between 0.05-0.1 mg/mL to maintain the quality of the media.
Sperm and ova products which contain more than 0.1mg/mL or 0.1mg/g total antibiotic substance, will be considered by the APVMA to be veterinary chemical products. These products are commonly used in AI procedures.
Sperm and ova products which contain less than or equal to 0.1mg/mL or 0.1mg/g total antibiotic substance, provided the product is not represented as being suitable for use as a veterinary chemical according to the definition in the Agvet Code, will not be considered by the APVMA to be veterinary chemical products. These products are commonly used in OT, IVF or ET procedures.
Albumin and Hyaluronic Acid (HA)
Albumin or hyaluronic acid (HA), both naturally occurring substances found as a normal part of body fluids, may be included in these products. These substances are more than simple nutrients in that they also protect sperm or ova from environmental and osmotic stress. There is no evidence that this protection is anything other than physical protection, and there is no evidence that these substances modify the physiology of the ‘animal’ other than as normal nutrients and as physical osmotic and thermal regulators.
Products containing albumin or hyaluronic acid, when used on sperm and ova during AI, OT, IVF or ET procedures, will not be considered by the APVMA to be veterinary chemical substances, provided that the products are not represented as being suitable for use as a veterinary chemical according to the Agvet Code.
It is important to note the requirement for an AQIS permit to import these substances or products containing them.
Glucose, electrolytes, amino acids and other metabolites
Glucose, electrolytes, amino acids and other metabolic precursors included in sperm and ova products will be considered by the APVMA to be exempt nutritional supplements when used at levels contained in normal body fluids.
Sperm and ova products used in AI, OT, IVF or ET procedures and containing glucose, electrolytes, amino acids and other metabolic precursors, will not be considered by the APVMA to be veterinary chemical substances, provided the product is not represented as being suitable for use as a veterinary chemical according to the definition in the Agvet Code.
EDTA, buffers and stabilising agents
EDTA, buffers and stabilising agents are not considered by the APVMA to be veterinary chemical substances.
Other ingredients
Products containing any other ingredient will be considered on a case-by-case basis. Full details should be submitted to the APVMA for assessment.
Summary Table
| Ingredient | Is this an active ingredient? | Is registration required for sperm and ova products containing this ingredient? |
|---|---|---|
| Antibiotics >0.1mg/mL or g | Yes | Yes |
| Antibiotics £0.1mg/mL or g | No | No* |
| Albumins | No | No* |
| Glucose, electrolytes & amino acids | No | No* |
| EDTA, buffers & stabilising agents | No | No* |
| Other | Considered case by case | Considered case by case |
*Provided the product is NOT represented as being suitable for:
- preventing, diagnosing, curing or alleviating a disease or condition in the animal or an infestation of the animal by a pest; or
- curing or alleviating an injury suffered by the animal; or
- modifying the physiology of the animal so as to alter its natural development, productivity, quality or reproductive capacity or so as to make it more manageable; or
- modifying the effect of another veterinary chemical product.