Agricultural and Veterinary Chemicals (MRL Standard for Residues of Chemical Products) Amendment Instrument (No. 5) 2025

Administered by Department of Agriculture, Fisheries and Forestry

Legislation au F2025L01448 Not in force Legislative Instrument

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Agricultural and Veterinary Chemicals (MRL Standard for Residues of Chemical Products) Amendment Instrument (No. 5) 2025

 

Explanatory Statement

Issued by the Australian Pesticides and Veterinary Medicines Authority

 

Introduction

The Australian Pesticides and Veterinary Medicines Authority (APVMA) is a statutory authority established under section 6 of the Agricultural and Veterinary Chemicals (Administration) Act 1992 (Admin Act).  The Admin Act implements the National Registration Scheme for Agricultural and Veterinary Chemicals (NRS) which is an intergovernmental scheme which facilitates the establishment and operation of the intergovernmental scheme for the national uniform regulation of agvet chemicals.

The APVMA’s functions and powers include administering the NRS, and exercising the powers and functions conferred on it by the Agricultural and Veterinary Chemicals Code, as scheduled to the Agricultural and Veterinary Chemicals Code Act 1994 (Code).

A prerequisite to the exercise of many of the APVMA’s powers under the Code in relation to registrable chemical products is its satisfaction that a product meets the safety criteria, among others. ‘Meets the safety criteria’ is defined at section 5A.

Subsection 5A(3)(b) provides a number of matters to which the APVMA may have regard for the purpose of being satisfied as to whether a chemical product meets the safety criteria. Those include (at subparagraph (iii))—

whether any trials or laboratory experiments have been carried out to determine the residues of the product and, if so, the results of those trials or experiments and whether those results show that the residues of the product will not be greater than limits that the APVMA has approved or approves.

‘Residues’ is defined in section 3 of the Code to include, in relation to an active constituent for a proposed or existing chemical product or in relation to a chemical product, ‘any remains, persisting in or on a protected commodity’ of the active constituent or chemical product.

Section 7A of the Admin Act authorises the APVMA to approve standards for residues of chemical products in protected commodities. These standards are then administered, applied and enforced by the jurisdictions who regulate the use of chemical products.

The Agricultural and Veterinary Chemicals (MRL Standard for Residues of Chemical Products) Instrument 2023 (2023 Instrument) approves by legislative instrument, standards for residues of chemical products in protected commodities in accordance with recent amendments made to section 7A of the Admin Act. The purpose of this instrument is to amend the 2023 Instrument so that it contains maximum residue limits required to support uses of agvet chemicals which have recently been approved by the APVMA.

How the maximum residues limits are determined

As part of its consideration in deciding whether to register a chemical product, the APVMA undertakes a comprehensive safety assessment.  An essential part of this is a residue risk assessment by the APVMA based on the uses proposed on the label. A key outcome of these assessments is the setting of a maximum residue limit (MRL) for a particular chemical in relation to nominated crops and animals.  An MRL is the maximum amount of a residue which would be expected if the agvet chemical product was used according to its label instructions approved by the APVMA. The acceptability of an MRL associated with a product use is based on a dietary risk assessment.

The setting of an MRL by the APVMA is a science-based outcome arising from these regulatory decisions.  There is only limited discretion on the part of the APVMA decision-maker in the establishment of an MRL, however a proposed MRL may be determined to be unacceptable based on anticipated human dietary exposure.

Process before instrument was made

Consultation before making

No additional public consultation was undertaken other than that which ordinarily occurs through the evaluation process of applications for registration and approval, which ultimately informs the maximum residue limits, was undertaken prior to making this instrument. Jurisdictions who regulate the use of chemical products, and reference the 2023 Instrument, are consulted as part of the evaluation process of applications for registration and approval.

During evaluation of a proposed chemical product or active constituent, any person may comment or raise concerns about any relevant aspect of the intended registration, sale and use of the chemical product, including proposed maximum residue limits and the dietary exposure assessment.  The APVMA addresses any concerns that are raised then, as part of that process.

Statement of compatibility with human rights obligations

This instrument is exempt from the requirements for a statement of compatibility with human rights as it is a non-disallowable instrument under section 44 of the Legislation Act.

Disallowance and Sunsetting

Pursuant to subsection 7A of the Admin Act, the 2023 Instrument and any subsequent amendments are legislative instruments for the purposes of the Legislation Act 2003, but it is not subject to the disallowance nor sunsetting provisions.

Although the 2023 Instrument and any subsequent amendments are legislative instruments for the purposes of the Legislation Act 2003, pursuant to subsections 44(1) and 54(1) it is not subject to the disallowance or sunsetting provisions of the Legislation Act 2003. Subsections 44(1) and 54(1) of the Legislation Act respectively provide that a legislative instrument is not disallowable or subject to sunsetting if the enabling legislation for the instrument (in this case, the Admin Act): (a) facilitates the establishment or operation of an intergovernmental scheme involving the Commonwealth and one or more States and (b) authorises the instrument to be made for the purposes of the scheme.

In accordance with sections 44(1) and 54(1) of the Legislation Act, the Admin Act is: part of a co-operative scheme involving the Commonwealth and all States and Territories which facilitates the establishment and operation of the NRS for Agricultural and Veterinary Chemicals which is an intergovernmental body and scheme; and authorises the 2023 Instrument to be made for the purposes of the NRS.

 

Other issues

More information

A provision-by-provision explanation of the Instrument is provided in Attachment A.

Notes on Items Attachment A

Item 1 – Name of instrument

This item provides for the Instrument to be named as the Agricultural and Veterinary Chemicals (MRL Standard for Residues of Chemical Products) Amendment Instrument (No. 5) 2025

Item 2 – Commencement

This item provides for the Instrument to commence on the day after the day it is registered.

Item 3 – Authority

This item provides that the Instrument is made under section 7A of the Agricultural and Veterinary Chemicals (Administration) Act 1992.

Item 4 – Schedules

This item gives the amendments their legal effect, by providing that each instrument specified in the Schedule is amended as set out in the applicable items of the Schedule.

Schedule 1

Schedule 1 contains the amendments to the MRL Standards in Schedule 1 of the principal instrument.

Overview

The Agricultural and Veterinary Chemicals (MRL Standard for Residues of Chemical Products) Amendment Instrument (No. 5) 2025, enacted by the Australian Pesticides and Veterinary Medicines Authority (APVMA), addresses the need to update the maximum residue limits (MRLs) for chemical products in protected commodities. This instrument amends the Agricultural and Veterinary Chemicals (MRL Standard for Residues of Chemical Products) Instrument 2023 to incorporate the MRLs required to support the recent approvals of agricultural and veterinary (agvet) chemicals by the APVMA. The APVMA’s role in assessing the safety of agvet chemicals includes determining appropriate MRLs based on comprehensive safety and residue risk assessments. The process of amending these standards involves ongoing consultation with relevant jurisdictions and stakeholders during the evaluation of chemical product applications, although no additional public consultation was undertaken specifically for this instrument. This legislative instrument is not subject to disallowance or sunsetting under the Legislation Act 2003 due to its role in facilitating the National Registration Scheme for Agricultural and Veterinary Chemicals.

Scope and Application

The Agricultural and Veterinary Chemicals (MRL Standard for Residues of Chemical Products) Amendment Instrument (No. 5) 2025 amends the 2023 Instrument to incorporate new maximum residue limits (MRLs) for agricultural and veterinary chemical products as approved by the Australian Pesticides and Veterinary Medicines Authority (APVMA). This legislation applies to all entities and individuals involved in the registration, sale, and use of agricultural and veterinary chemicals within Australia, including producers, distributors, and end-users of these chemicals. The MRLs are set to ensure the safety of these chemicals for human consumption and environmental protection when used as directed. The instrument's jurisdictional reach is national, reflecting its role within the intergovernmental National Registration Scheme for Agricultural and Veterinary Chemicals. There are no exclusions or exemptions specified in this instrument, but the setting of MRLs is subject to rigorous safety assessments by the APVMA. The application of the instrument is not subject to disallowance or sunsetting provisions under the Legislation Act 2003, given its role in facilitating an intergovernmental scheme. The instrument extends the application of the MRL standards through its amendments to the 2023 Instrument, ensuring the continued regulation of chemical products in protected commodities.

Key Provisions

The main operative sections of the Agricultural and Veterinary Chemicals (MRL Standard for Residues of Chemical Products) Amendment Instrument (No. 5) 2025 are those that amend the maximum residue limits (MRLs) for residues of chemical products in protected commodities. Section 3 of the Instrument outlines the amendments to the MRLs, which are specified in Schedule 1. These sections essentially update the MRLs to reflect the recent approvals of agricultural and veterinary (agvet) chemical products by the Australian Pesticides and Veterinary Medicines Authority (APVMA). The Act imposes several obligations on parties involved with the registration and use of agvet chemicals. Firstly, it mandates that any proposed MRLs must be scientifically justified and based on comprehensive safety assessments conducted by the APVMA, including residue risk assessments. The MRLs must be set in such a way that anticipated human dietary exposure is acceptable. Secondly, it requires that the APVMA consult with relevant jurisdictions during the evaluation of chemical products to ensure that the MRLs are appropriate and enforceable. Finally, it mandates that the APVMA address any concerns raised by the public regarding the proposed MRLs and dietary exposure assessments as part of the registration process. Breaching the provisions of this Act can result in significant consequences. Firstly, any entity found to be in violation of the approved MRLs could face enforcement actions from the relevant jurisdiction regulating the use of chemical products. This could include fines, sanctions, or even revocation of the chemical product’s registration. Secondly, there are potential civil consequences for individuals or entities whose products exceed the approved MRLs, as consumers or businesses could seek damages for any harm caused by the residues. While the Act itself does not specify maximum penalties, the severity of the penalties would be determined by the jurisdiction enforcing the MRLs, and could include substantial fines and legal costs. In conclusion, this legislative instrument plays a crucial role in ensuring that the use of agvet chemicals in Australia is safe for human consumption and the environment. By setting and enforcing MRLs, the Act helps to protect public health and maintain the integrity of the agricultural and veterinary sectors. Compliance with these provisions is essential for all stakeholders involved, from manufacturers and distributors to end-users of these chemical products.

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Sourced from the Federal Register of Legislation at 26 August 2026. For the latest information on Australian Government law please go to https://www.legislation.gov.au.