Agricultural and Veterinary Chemicals Code (Allowable Variation in Concentrations of Constituents in Agricultural Chemical Products) Standard 2022

Administered by Department of Agriculture, Fisheries and Forestry

Legislation au F2022L01068 In force Legislative Instrument

Legislation content

Agricultural and Veterinary Chemicals Code (Allowable Variation in Concentrations of Constituents in Agricultural Chemical Products) Standard 2022

 

Explanatory Statement

Issued by the Australian Pesticides and Veterinary Medicines Authority

 

Introduction

The Australian Pesticides and Veterinary Medicines Authority (APVMA) is a statutory authority continued in existence under section 6 of the Agricultural and Veterinary Chemicals (Administration) Act 1992.  Its functions and powers include administering the national system for regulation of agricultural and veterinary chemicals, 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).

Under section 6E(1)(b) of the Code, APVMA may make standards for chemical products by legislative instrument. Section 87(2)(a) of the Code prohibits a person from supplying, or causing or permitting to be supplied, a product where a standard is prescribed in respect of that product unless the product conforms to the standard. Regulation 42(3) of the Agricultural and Veterinary Chemicals Code Regulations 1995 (Regulations) provides a cascade of standards for products or constituents contained in products, with step 2 of the cascade (regulation 42(3)(b)) being a standard made under section 6E of the Code.

This Instrument establishes a standard under section 6E of the Code for agricultural chemical products.

Process before instrument was made

Regulatory impact analysis

A Regulatory Impact Statement has not been prepared. The Office of Best Practice Regulation (OBPR) was consulted about this Instrument and related instruments for specifying allowable variation in products and active constituents which may be established in the future (OBPR ID OBPR22-02871).

On the basis of the information provided, OBPR considered that a Regulatory Impact Statement is not required for this Instrument (or other related instruments) as the making of this Instrument is likely to have no more than minor regulatory impacts on business, community organisations or individuals and is not being considered by Cabinet.

Consultation before making

Prior to making the Instrument under section 6E of the Code to create the standard specifying the prescribed extent of the variation from the concentration on the Register allowed for concentrations of constituents in agricultural chemical products, the proposed standard was consulted on via a formal process via the APVMA website and by targeted consultation with key stakeholders.

Statement of compatibility with human rights obligations

A statement of compatibility has been prepared and is at Attachment A.

Other issues

Matter incorporated by reference

The Instrument incorporates by reference the matters contained in the document, Validation of analytical methods for active constituents and agricultural products (Validation Guidance Document) for the purposes of the Validated Analytical Methods defined in subsection 4(2) of Part 1 of the Instrument.

Subsection 6E(2) of the Code provides that a standard made under subsection (1) may apply, adopt or incorporate, with or without modification, any matter contained in any instrument or other writing as in force at a particular time or as in force from time to time. In accordance with subsection 6E(2) of the Code, the Validation Guidance Document is incorporated as in force from time to time.

The Validation Guidance Document sets out procedures for validating analytical methods used to generate analytical results provided by applicants as scientific evidence in support of their applications to the APVMA. This guidance document assists applicants to demonstrate that the nominated method, when correctly applied, produces results that are fit for purpose when providing evidence to the APVMA that certain required statutory criteria are met under the Code as part of the APVMA’s assessment of the application.

The Validation Guidance Document may be viewed or downloaded free of charge from the APVMA’s website (https://www.apvma.gov.au).  

Sunsetting

The Instrument is not subject to sunsetting as the Code facilitates the operation of a scheme involving the Commonwealth and one or more States or Territories and authorises the Instrument to be made by the APVMA under section 6E for the purposes of the scheme, namely the national regulatory system for agricultural and veterinary chemicals.

More information

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

Statement of Compatibility with Human Rights Attachment A

Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011

Agricultural and Veterinary Chemicals Code (ALLOWABLE VARIATION IN CONCENTRATIONS OF CONSTITUENTS IN AGRICULTURAL CHEMICAL PRODUCTS) Standard 2022

This Legislative Instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.

Overview of the Legislative Instrument

The purpose of this Instrument is to establish a standard for prescribing under section 6E of the Code the extent to which the measured concentrations of constituents of registered agricultural chemical products may vary from the concentrations recorded in the Register.

Human rights implications.

The Instrument does not engage any of the applicable rights or freedoms.

Conclusion

The Instrument is compatible with human rights as it does not raise any human rights issues.

Notes on Items Attachment B

Part 1

Item 1 – Preamble

This item provides that the Instrument is made under section 6E of the Code, following the procedure in regulation 8AF of the Regulations. It also states that under regulation 42(3) of the Regulations, a standard made under section 6E of the Code is a prescribed standard for a chemical product for the purposes of section 87(1)(a) of the Code.

Item 2 – Name of instrument and authority

This item provides for the Instrument to be named as the Agricultural and Veterinary Chemicals Code (Allowable Variation in Concentrations of Constituents in Agricultural Chemical Products) Standard 2022 and confirms that the authority for making it is section 6E(1) of the Code.

Item 3 – Commencement

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

Item 4 – Definitions

This item describes the definitions used in the Instrument.

Part 2

Item 1 – Prescribed extent of allowable variation for concentrations of active constituents in agricultural chemical products

This item specifies the extent to which the concentration of an active constituent in a registered agricultural chemical product may, when measured, differ from the concentration declared and recorded in the Register for that active constituent in the product.

Item 2 – Prescribed extent of allowable variation for concentrations of non-active constituents in agricultural chemical products

This item specifies the extent to which the concentration of a non-active constituent in a registered agricultural chemical product may, when measured, differ from the concentration declared and recorded in the Register for that non-active constituent in the product.

 

Overview

The Agricultural and Veterinary Chemicals Code (Allowable Variation in Concentrations of Constituents in Agricultural Chemical Products) Standard 2022 was enacted to provide a framework for the allowable variation in concentrations of constituents in agricultural chemical products, ensuring consistency and compliance with the Agricultural and Veterinary Chemicals Code Act 1994. This legislative instrument was introduced by the Australian Pesticides and Veterinary Medicines Authority (APVMA), a statutory authority established under section 6 of the Agricultural and Veterinary Chemicals (Administration) Act 1992. The policy objective is to maintain the quality and efficacy of agricultural chemical products by setting specific standards for the allowable variation in concentrations of active and non-active constituents. This standard ensures that the products supplied in the market meet the required specifications, thereby protecting public health and the environment. The Standard was developed following a formal consultation process via the APVMA website and targeted consultations with key stakeholders. A Regulatory Impact Statement was not deemed necessary as the instrument is expected to have minor regulatory impacts. Additionally, a Statement of Compatibility with Human Rights has been prepared, confirming that the Standard does not engage any of the applicable rights or freedoms and is therefore compatible with human rights. The Standard incorporates by reference the Validation Guidance Document for analytical methods, which assists applicants in demonstrating that the methods used to generate analytical results are fit for purpose. This ensures that the evidence provided to the APVMA meets the required statutory criteria, facilitating effective assessment of applications under the Code.

Scope and Application

The Agricultural and Veterinary Chemicals Code (Allowable Variation in Concentrations of Constituents in Agricultural Chemical Products) Standard 2022, issued by the Australian Pesticides and Veterinary Medicines Authority (APVMA), pertains to the allowable variations in the concentrations of constituents within agricultural chemical products. This standard applies to entities and individuals involved in the production, distribution, and sale of agricultural chemicals within Australia. It sets specific limits on the allowable variations in the concentrations of both active and non-active constituents from those declared and recorded in the Register. The standard aims to ensure that agricultural chemical products meet specific regulatory requirements before they are supplied. Geographically, the Act operates under the national regulatory system for agricultural and veterinary chemicals, extending across all states and territories within Australia. It incorporates by reference the Validation Guidance Document to assist in the validation of analytical methods, ensuring that the analytical results are fit for purpose. The Instrument is not subject to sunsetting, allowing it to remain in effect as long as necessary to regulate agricultural chemicals effectively. The APVMA, as the statutory authority, is empowered to make this standard under section 6E of the Agricultural and Veterinary Chemicals Code Act 1994.

Key Provisions

The primary sections of the Agricultural and Veterinary Chemicals Code (Allowable Variation in Concentrations of Constituents in Agricultural Chemical Products) Standard 2022 (the "Standard") establish the allowable variations in the concentrations of active and non-active constituents in registered agricultural chemical products. Specifically, Part 2, Item 1 of the Standard specifies the permissible variations for active constituents, while Part 2, Item 2 details the allowable variations for non-active constituents. These provisions aim to ensure that the chemical products supplied in the market meet the required standards of consistency and safety as recorded in the Register maintained by the Australian Pesticides and Veterinary Medicines Authority (APVMA) (sections 4 and 5). The Standard imposes several obligations on entities involved in the supply of agricultural chemical products. Firstly, it mandates that any person supplying agricultural chemical products must ensure that the concentrations of their active and non-active constituents do not exceed the allowable variations specified in the Standard (section 87(2)(a) of the Agricultural and Veterinary Chemicals Code Act 1994). This requirement ensures that the products supplied are consistent with the concentrations recorded in the Register, thereby maintaining product quality and safety standards. Additionally, the Standard incorporates by reference the Validation of analytical methods for active constituents and agricultural products, requiring that analytical methods used to determine constituent concentrations must be validated in accordance with the procedures outlined in the Validation Guidance Document (section 6E(2) of the Code). Failure to comply with the Standard may result in significant legal consequences. Under section 87(2)(a) of the Agricultural and Veterinary Chemicals Code Act 1994, any person who supplies a product that does not conform to the Standard may be subject to enforcement actions. The potential penalties for non-compliance may include fines and other sanctions as prescribed by the Agricultural and Veterinary Chemicals Code Act 1994 and the Agricultural and Veterinary Chemicals Code Regulations 1995. The specific penalties for breaches may vary based on the severity and circumstances of the non-compliance. It is essential for suppliers to adhere to the Standard to avoid these legal repercussions.

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Chemical Regulation
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Standard
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Definitions & Interpretation
Regulatory Standards
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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.