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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 Australian Pesticides and Veterinary Medicines Authority (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 agricultural 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:
- the APVMA considers 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.
There are currently 2 groups of active constituent approved under section 14A of the Agvet Code:
- Active constituents approved under section 14A with the applicant as the approval holder on the basis of a limited dataset sufficient to satisfy APVMA with respect to the safety criteria. These active approvals are searchable in PubCRIS, and will have the applicant’s name recorded in the registrant field. An active approved under section 14A of the Agvet Code and held by the applicant is not distinguishable in PubCRIS from an active approved under section 14 of the Agvet Code. Like actives approved under section 14 of the Agvet Code, an active constituent approved under section 14A of the Agvet Code must be obtained from an approved manufacturing site.
- 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. In this situation, the APVMA is the holder of the active constituent approval. Approximately 60 actives have been approved under section 14A with APVMA as the holder. These actives can be searched in PubCRIS, and can be identified by ‘AUSTRALIAN PESTICIDES & VETERINARY MEDICINES AUTHORITY’ being recorded in the registrant field. These actives may be obtained from any source capable of manufacturing the active to a specification suitable for use in the registered product. It should be noted that APVMA is no longer approving active constituents with APVMA as the holder.
APVMA assesses each active constituent to be approved under section 14A using available information on the safety?(including chemistry and toxicological information)?of that active constituent.
Active constituents exempted from the requirement for approval
A number of active constituents have been exempted from the requirement for approval (i.e. exempted from the operation of section 15(1)(a)(i) of the Agvet Code), through a formal process involving a gazettal of the active as exempt from approval.
The list of exempted actives 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. 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.
Exempt active constituents do not have approval numbers associated with them and do not appear in APVMA’s record of approved active constituents for chemical products and registered products database PubCRIS. These actives do not require approval, and may be obtained from any source capable of manufacturing the active to a specification suitable for use in the registered product.
The list of exempt actives has not been added to for a number of years and APVMA is not routinely considering new exemptions.
Use in agricultural and veterinary chemical products
If an active constituent is approved under section 14A of the Agvet Code (either with the applicant as holder, or with APVMA as the holder), or is exempted from the requirement for approval, 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 exempted from approval or approved under section 14A will be subject to the same evaluation process as that required for all products. Each product must be separately registered by the APVMA before it can be legally sold, distributed or used.