This consultation closed on 8 July 2025
The Australian Pesticides and Veterinary Medicines Authority (APVMA) proposes to make a standard, by legislative instrument under section 6E of the Agricultural and Veterinary Chemicals Code scheduled to the Agricultural and Veterinary Chemicals Code Act 1994 (Agvet Code) for certain agricultural and veterinary chemical products containing malathion (also known as maldison) as an active constituent. The proposed standard is the Agricultural and Veterinary Chemicals Code (Chemical Products) Standard 2025 (Chemical Products Standard).
Under regulation 8AF of the Agricultural and Veterinary Chemicals Code Regulations (the Agvet Code Regulations), the APVMA must publish a notice in the Gazette and on the APVMA’s website that it proposes to make the Chemical Products Standard.
The draft Chemical Products Standard is available on apvma.gov.au. This notice has also been published in the Gazette No 12, Tuesday 10 June 2025.
Reasons why the APVMA considers it necessary to make this Standard
In undertaking its recent reconsideration of malathion, the APVMA identified a risk to users from toxic impurities formed during manufacture and storage of products containing malathion. To treat this risk, the APVMA imposed several new controls on products containing malathion, including making a standard to limit impurities in products containing malathion as an active constituent. Further information on the APVMA’s final regulatory decision on malathion can be found in the APVMA Special Gazette, 2 May 2024.
If made, the Chemical Products Standard, will be made under subsection 6E(1) of the Agricultural and Veterinary Chemicals Code (Code) contained in the Schedule to the Agricultural and Veterinary Chemicals Code Act 1994. It specifies the proposed acceptable levels (minimum, maximum or range as appropriate) for concentrations of malathion active constituents and toxicologically significant impurities consistent with the scientific assessments conducted as part of the chemical review of malathion. If the toxic impurities in products containing malathion as an active constituent exceed prescribed limits, they will pose an unacceptable risk to safety, particularly the safety of people using the products.
Accordingly, the Chemical Products Standard will help ensure that continued use of products containing malathion are safe for people, plants, animals and the environment by setting limits for toxic impurities.
Due to the effect of the existing legislation, if the Chemical Products Standard is made, a person may commit an offence or be liable to pay a civil penalty if the person supplies a product containing malathion, or causes or permits such a product to be supplied, if the product does not conform with the prescribed limits (see paragraph 87(2)(a) of the Code and subregulation 42(3) of the Agricultural and Veterinary Chemicals Code Regulation 1995).
In considering whether it is necessary to make the Chemical Products Standard the APVMA has had regard to a relevant standard specified under regulation 8AF(a) of the Agvet Code Regulations, the FAO/WHO specification for malathion as it related to relevant malathion product formulation types. The proposed Chemical Products Standard has been harmonised with the FAO/WHO specification as far as possible, but there are some differences in the impurities specified and their limits supported by the toxicological and stability data assessments conducted for the reconsideration of malathion, as described in the chemistry assessment report.
Should the proposed standard be made, it would be updated as required to include new product standards, and to make any changes necessary to existing standards, such as in conjunction with a chemical review. All such changes would be consulted on as required under regulation 8AF.
Further information on the proposed standard can be obtained from the contact details given below.
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Links to the relevant legislative references are provided below:
Agricultural and Veterinary Chemicals Code Act 1994
Agricultural and Veterinary Chemicals Code Regulations 1995
Submissions received
The APVMA sought consultation from interested stakeholders on the proposed Agricultural and Veterinary Chemicals Code (Chemical Products) Standard 2025, in a consultation that closed on 8 July 2025. No submissions were received. The APVMA will therefore proceed to make the new instrument on the Federal Register of Legislation.