This content is current only at the time of printing. This document was printed on 19 October 2018. A current copy is located at https://apvma.gov.au/node/10701
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Approval of active constituents
The following information is derived from section 14 and section 14A of the Agricultural and Veterinary Chemicals Code (Agvet Code).
Agricultural and veterinary chemical products are often complex mixtures of active constituents, solvents, diluents, stabilisers and other substances. Active constituents are the components of agricultural and veterinary chemical products that are primarily responsible for the biological or therapeutic effects of the products.
Section 14: Grant or refusal of application
Section 14 of the Agvet Code requires that, before granting an application for the approval or registration of a chemical product, the APVMA must be satisfied that the use of that product will not have a harmful effect on human health, the environment, occupational health and safety or trade, and that the product is effective for its intended use. In particular, the APVMA is required to separately approve each of the active constituents present in a formulated product. Our primary responsibilities in approving an active constituent are to ensure that each active constituent:
- complies with the appropriate standard, such as the European Pharmacopoeia, the British Pharmacopoeia (veterinary), the United States pharmacopeia, the APVMA published standard for technical grade active constituents or any other publication we consider to be appropriate
- is of a known minimum purity
- has a known toxicological profile.
Section 14A: Approval of active constituents for which information is not readily available
Section 14A of the Agvet Code allows the APVMA to approve active constituents for a proposed or existing chemical product as described in section 11(1)(b), if:
- we consider that the information is not readily available, or
- the active constituent is, or is part of, a product in respect of which a standard is specified in the European Pharmacopoeia, the British Pharmacopoeia (veterinary), the United States Pharmacopeia or any other publication we consider to be appropriate.
Under section 14A of the Agvet Code, the APVMA on our own initiative may approve an active constituent where an application has not been received under section 10 of the Agvet Code. To do this, we must be satisfied that the active constituent is well known, is in common use and has a history of safety in the context of use.
We are currently reviewing the list of active constituents that qualify for approval under section 14A. The list includes active constituents that have been in common use for many years but were not primarily developed as agricultural or veterinary chemicals, and whose characteristics are well known. The active constituent approved under section 14A can be found on the current exempt list. These 'exempt actives' can be found in household or industrial chemicals, solvents, surfactants and oils used to dilute or spread other agricultural chemicals or to modify a physical property; and in a number of disinfectants and biocides used to control moulds and fungi in agriculture.
We assess each active constituent to be approved under section 14A using available information on the health, safety, trade and efficacy of that active constituent.
If an active constituent is approved under section 14A of the Agvet Code, the code still requires that the APVMA is satisfied that the products containing the active constituents do not endanger people, animals or plants, the environment or Australia’s international trade. Any product containing an active constituent approved under section 14A will be subject to the same evaluation process as that set out for all products. Each product must be separately registered by the APVMA before it can be legally sold, distributed or used.