This content is current only at the time of printing. This document was printed on 24 March 2017. A current copy is located at http://apvma.gov.au/node/1104
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Access to safe and effective agricultural and veterinary chemicals
Australians need access to safe and effective agricultural and veterinary (agvet) chemicals to control pests and diseases on animals and plants. Because of the potential risks from the incorrect use of agvet chemicals, the Australian Government has, for many years, played a key role in the regulation of pesticides and veterinary medicines. Regulatory measures are in place to ensure these chemicals work, but are also safe for humans, non-target animals and plants, and the environment.
Agvet chemical products consist of one or more active constituents and may also contain other non-active constituents (or excipients). The active constituents are responsible for the biological or other effects of the product. The non-active active constituents are included for a range of reasons, such as stabilising the product, acting as a carrier for the active constituent or improving the properties of the product (for example, solubility or dispersion).
Under the existing national controls for agvet chemicals, it is a serious offence for any person to import an agvet chemical product into Australia or to distribute or sell a chemical product in any state or territory in Australia, if that product has not been registered by the APVMA for that state or territory (subject to certain exceptions).
All active constituents for agvet chemical products must be approved by the APVMA (subject to certain exceptions). It is a serious offence for any person to sell a chemical product that does not have an APVMA-approved label attached to its container (subject to certain exceptions).
What are ‘active constituents’?
Active constituents are the substances in an agricultural or veterinary chemical product that are primarily responsible for the product’s biological or other effect identifying the product as an agricultural or veterinary chemical product (as the case may be). Generally, an active constituent must be approved either before or at the same time as the chemical product containing it is registered. A limited number of active constituents are exempt from APVMA approval process or can be approved with the APVMA as the holder where information needed to register them is not readily available.
Agvet chemical product registration
If we decide to grant an application for registration of a chemical product and approve the proposed label, we must register the chemical product by entering certain information about it in the Register, and approve the label for the product by giving it a distinguishing number and recording certain information about it in the relevant APVMA file.
Once a chemical product has been registered and its label approved, it can then be legally distributed, sold and used in all Australian states and territories in which the product has been registered for use and which are described on the chemical product label.
If a holder later wants to vary any of the ‘particulars’ of registration as entered in the Register or to make any variation to the approved label for the chemical product—including making additional claims about the chemical product—they will need to apply to us seeking approval for the proposed variations.
Registration ensures that users have access to chemical products that are correctly packaged and labelled with all necessary limitations, precautions and directions for use. Registration of agvet chemical products also provides an assurance that these products are safe and effective when used according to label instructions.
Registration also helps to ensure that unacceptable residues from the chemicals used in agriculture do not appear in food for human or animal consumption in Australia, or destined for export.
Agvet permit approval
The Agvet Code requires that all agvet chemical products sold in Australia be registered by the APVMA (subject to certain exceptions).
In most states and territories, registered chemical products must only be used for the purposes specified on the label. However, in practice, situations often arise where chemical products are needed for a use not specified on the label—‘off-label’ uses. We can consider applications for permits that allow for the legal use of chemical products in ways different from the uses set out on the chemical product label. We can also consider applications for permits allowing limited use of an unregistered chemical product.
In addition, we may issue a permit to persons (including individuals, organisations or corporations) allowing them (or others) to use a particular agvet chemical product in a limited way (that is, for minor uses, emergency uses or research purposes) when that chemical product either is not registered or the proposed use is contrary to the use instructions and directions on the approved label.