Approval of Active Constituents
Approval of Active Constituents via Section.14A of the Agricultural and Veterinary Chemicals Code Act
Agricultural and veterinary chemical products are often complex mixtures of the active constituent(s), solvents, diluents, stabilisers and other substances. Active constituents are substances within agricultural and veterinary chemical products that are primarily responsible for the biological or therapeutic effect of the product.
Section 14 of the Agvet Code requires that, before granting an application for approvals or registrations, the Australian Pesticides and Veterinary Medicines Authority (APVMA) must be satisfied that the use of a chemical 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 the active constituent(s). The APVMA’s primary responsibility in approving active constituents is to ensure that active constituents comply with an appropriate standard and do not contain unacceptable levels of potentially harmful impurities.
Requirements of the amended Agvet Code
Section 14A of the amended Agvet Code allows the APVMA to approve active constituents for a proposed or existing chemical product, if the APVMA considers that the information it requires under paragraph 11(1)(b)] is 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 Pharmacopoeia or any other publication considered by the APVMA to be appropriate
Under s14A of the amended Agvet Codes, the APVMA on its own initiative may approve an active constituent. The APVMA must be satisfied that the active constituent is well known, in common use and has a history of safety in the context of use.
The APVMA is reviewing the list of active constituents that qualify for approval under section 14A. This list will include active constituents that have been in common use for many years but which have not been primarily developed as agricultural/veterinary chemicals and whose characteristics are well known. For example, certain active constituents in the current exempt list, and active constituents that are present in household or industrial chemicals, solvents, surfactants and oils used to dilute or spread other agricultural chemicals, a number of disinfectants and biocides used to control moulds and fungi in agriculture.
Each active constituent to be approved under s14A will be assessed by the APVMA, using available information on the health, safety, trade and efficacy matters.
If an active constituent is approved under Section 14A of the Agvet Code still requires that the APVMA be satisfied that the products containing these actives do not endanger people, animals or plants, the environment or Australia’s International trade. Any product containing active constituent(s) approved under s 14A will be subject to the same evaluation process as set out for all products and that the product must be separately registered by the APVMA before that product can be legally sold distributed or used.
Information about applications and fees
Phone: +61 2 6210 4818