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Australia New Zealand Food Standards Code—Schedule 20–maximum residue limits Variation Instrument No. APVMA 5, 2019

Australia New Zealand Food Standards Code—Schedule 20–maximum residue limits Variation Instrument No. APVMA 5, 2019

Administered by Department of Health, Disability and Ageing

Legislation au F2019L01059 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

Australia New Zealand Food Standards Code—

Schedule 20—Maximum Residue Limits

Variation Instrument No. APVMA 5, 2019

Subsection 82(1) of the Food Standards Australia New Zealand Act 1991 provides that the Australian Pesticides and Veterinary Medicines Authority (APVMA) may vary the Maximum Residue Limits Standard to include or change a permitted maximum residue limit. The Maximum Residue Limits Standard in the Australia New Zealand Food Standards Code (Food Standards Code) is Schedule 20 — Maximum Residue Limits.

Schedule 20 is the Principal Instrument being amended by this Amendment Instrument. It has existed in various forms since before the Food Standards Code was first published in 1997.

Section 82 was part of amendments to the Food Standards Australia New Zealand Act 1991 (FSANZ Act), which were proclaimed to commence on 1 March 2011, that implemented a 2008 reform agreed to by the Council of Australian Governments (COAG) calling for the recognition by Food Standards Australia New Zealand (FSANZ) of the APVMA’s residue risk assessment and the promulgation of the resulting MRLs in the Food Standards Code, for domestically grown produce. The reform was designed to streamline current regulatory processes and to eliminate duplication by allowing the APVMA to directly vary Schedule 20.

The APVMA is an independent statutory authority of the Commonwealth. Amongst other things, the APVMA is responsible for ensuring agricultural and veterinary (agvet) chemicals used in Australia are not harmful to public health due to residues in food.

The Agreement between the Government of Australia and the Government of New Zealand concerning a Joint Food Standards System excludes MRLs for residues of agvet chemicals in food from the system setting joint food standards. Australia and New Zealand independently and separately develop MRLs for agvet chemicals in food.

Assessment and Determination of MRLs

MRLs are regulatory standards which help to monitor that the agvet chemical product has been used in accordance with the approved label instructions. If an MRL is exceeded, it usually indicates a misuse of the chemical but does not normally indicate a public health or safety concern.

In evaluating the safety and performance of agvet chemicals, the APVMA’s assessment also includes a determination of an MRL for the chemical in relation to relevant crops and animals. The APVMA uses data from a series of residue trials and calculates whether the application of the minimum amount of chemical that is required to achieve effective pest or disease control will leave any residue in the plant or animal commodity. In order to legitimise the presence of these residues, MRLs are established by the APVMA by entry into the APVMA’s MRL Standard (available at http://www.comlaw.gov.au).

If there are small amounts of chemical residue in produce, the APVMA uses the toxicological evaluation and the dietary exposure assessment to examine the potential occurrence of adverse effects on human health when the produce is consumed.

Dietary exposure assessments undertaken by the APVMA as part of the registration of the relevant chemical products indicate that the MRL variations being made by the Amendment Instrument do not present any public health and safety concerns.

Schedule 20 of lists the maximum level of the residues of an agvet chemical that may occur in foods. Including limits for residues of agvet chemicals in foods in the Food Standards Code has the effect of allowing the sale of food containing legitimate residues, where any residues do not exceed these limits. Variations in MRLs reflect the changing use patterns of agvet chemicals available to chemical users including food producers. These changes include both the development of new products and crop uses, and the withdrawal of older products following review by the APVMA.

Regulatory Impact Assessment

The proposed changes to regulation are minor and machinery in nature involving necessary technical variations to the Food Standards Code. In November 2010, the Office of Best Practice Regulation provided a standing exemption from the need to assess if a Regulatory Impact Statement is required for applications relating to variations to MRLs.

The proposed MRL amendments are an essential consequence of the decision by the APVMA to register agvet chemical products (or to vary and extend their approved label instructions); or to issue a permit in relation to an agvet chemical product; or an outcome of a review decision by the APVMA to withdraw or restrict older agvet chemical products. The setting of an MRL and its incorporation in the Food Standards Code is a science-based outcome arising from these decisions and for which there is only very limited discretion on the part of the APVMA decision maker.

The proposal to vary MRLs in the Food Standards Code is likely to have negligible impacts on business, individuals, regulatory agencies or the economy. Primary producers understand the need to use only registered agvet chemical products and to use those products strictly in accordance with approved label instructions. In doing so, produce grown will be within the MRL set by the APVMA and, with the incorporation of those MRLs into the Food Standards Code by this Amendment Instrument, the sale of the produce containing residues that do not exceed the MRL will be lawful. To this extent, the incorporation of APVMA approved MRLs into Schedule 20 of the Food Standards Code benefits rather than burdens primary producers and consumers.

Consultations

The APVMA seeks the wider community’s involvement through public consultation as part of its evaluation process for the registration of new agvet chemical products or a major extension of the use of existing products to new crops and target animals. During this consultation phase any person may comment or raise concerns about any relevant aspect of the intended registration, sale and use of the chemical product, including proposed MRLs and the dietary exposure assessment. The APVMA addressed any concerns that were raised at the time as part of the registration and approval process.

More specifically, by way of notice in the Agricultural and Veterinary Chemicals Gazette (No. APVMA 4) on 26 February 2019, (No. APVMA 7) on 9 April 2019 and (No. APVMA 10) on 21 May 2019 the APVMA notified that it was proposing to incorporate these variations to MRLs into Schedule 20 and it invited public comment on the proposals. The APVMA did not receive any comments during this stage of the consultations.

A Sanitary and Phytosanitary notification to the World Trade Organization (WTO) was also made in relation to the variations to MRLs in Schedule 20 and comment was received in response to that notice and consultations are continuing.

Variations to MRLs are Legislative Instruments

Pursuant to subsection 82(2) of the FSANZ Act, the variations to MRLs made by the Amendment Instrument is a legislative instrument for the purposes of the
Legislation Act 2003, but it is neither subject to the disallowance nor sunsetting provisions.

NOTES ON ITEMS

Item 1 Name of Instrument

1. This item states that the full name of the Amendment Instrument is the Australia New Zealand Food Standards Code — Schedule 20 — Maximum Residue Limits Amendment Instrument No. APVMA 5, 2019.

Item 2 Commencement

2. Subsection 82(8) of the Food Standards Australia New Zealand Act 1991 has the effect that, despite the provisions in the Legislation Act 2003, a legislative instrument made by the APVMA varying Schedule 20 commences on the day a copy of the variation is published in the Gazette.

3. A Note to the item records that a copy of the variations made by the Amendment Instrument was published in the Commonwealth of Australia Agricultural and Veterinary Chemicals Gazette.

Item 3 Object

4. This item provides that the object of this Amendment Instrument is for the APVMA to vary Schedule 20 of the Food Standards Code to include or change MRLs pertaining to agricultural and veterinary chemical products.

Item 4 Interpretation

5. This item defines the APVMA and the Principal Instrument.

6. The APVMA is the Australian Pesticides and Veterinary Medicines Authority established by section 6 of the Agricultural and Veterinary Chemicals (Administration) Act 1992.

7. The Principal Instrument is Schedule 20 — Maximum Residue Limits of the Australia New Zealand Food Standard Code as defined in Section 4 of the Food Standards Australia New Zealand Act 1991 being the code published in Gazette
No. P 27 on 27 August 1987 together with any amendments of the standards in that code.

8. The definition of Principal Instrument also notes that Schedule 20 was published in the Food Standards Gazette FSC 96 on Thursday 10 April 2015 and was registered as a legislative instrument on 1 April 2015 F2015L00468.

Item 5 Variations to Schedule 20

9. This item provides that the Schedule to this Amendment Instrument sets out the variations to Schedule 20 – Maximum Residue Limits of the Food Standards Code.

10. The variations to MRLs made by the Amendment Instrument include variations made by the APVMA to the MRL Standard for February, April and May 2019 comprising amendments numbered (Agricultural and Veterinary Chemicals Code Instrument No. 4 (MRL Standard) Amendment Instrument 2019 (No. 2, 3 and 4)) inclusive.

By Authority:

Chief Executive Officer

Delegate of the APVMA

7 August 2019

STATEMENT OF COMPATIBILITY FOR A LEGISLATIVE INSTRUMENTTHAT DOES NOT RAISE ANY HUMAN RIGHTS ISSUES

Overview

The Australia New Zealand Food Standards Code—Schedule 20—Maximum Residue Limits Variation Instrument No. APVMA 5, 2019 was enacted to address the need for streamlined regulatory processes in setting Maximum Residue Limits (MRLs) for agricultural and veterinary (agvet) chemicals in food. This legislative instrument was introduced by the Australian Pesticides and Veterinary Medicines Authority (APVMA), an independent statutory authority responsible for ensuring the safety of agvet chemicals used in Australia. The primary policy objective is to incorporate APVMA-approved MRLs into the Food Standards Code, facilitating the lawful sale of food containing legitimate residues within the specified limits. This legislative action was necessitated by a 2008 reform agreed upon by the Council of Australian Governments (COAG), which recognised the APVMA’s role in residue risk assessment and sought to eliminate regulatory duplication. By allowing the APVMA to directly vary Schedule 20 of the Food Standards Code, the reform aimed to harmonise MRLs with the approved use of agvet chemicals, ensuring both public health protection and efficient agricultural practices.

Scope and Application

The Australia New Zealand Food Standards Code—Schedule 20—Maximum Residue Limits Variation Instrument No. APVMA 5, 2019 is an amendment to the Food Standards Code, which governs the maximum allowable levels of residues of agricultural and veterinary (agvet) chemicals in food. This legislation applies to all entities involved in the production, processing, and sale of food products within Australia, including farmers, food manufacturers, and distributors. The APVMA, an independent statutory authority responsible for ensuring the safety of agvet chemicals, has the authority to vary these maximum residue limits (MRLs) as part of its regulatory functions. The variation of MRLs in the Food Standards Code is a science-based outcome reflecting the changing use patterns of agvet chemicals. The variations are intended to ensure that any residues in food do not exceed the established limits, thereby maintaining public health and safety. The amendments to Schedule 20, the Principal Instrument, are legislative instruments and come into effect on the day of their publication in the Gazette. This legislative instrument neither falls under disallowance nor sunsetting provisions. The variations to the MRLs are not subject to public consultation except for notices published in the Agricultural and Veterinary Chemicals Gazette and a Sanitary and Phytosanitary notification to the World Trade Organization.

Key Provisions

The Australia New Zealand Food Standards Code—Schedule 20—Maximum Residue Limits Variation Instrument No. APVMA 5, 2019 (the Instrument) amends the Maximum Residue Limits Standard (MRL Standard) in Schedule 20 of the Australia New Zealand Food Standards Code. This amendment, pursuant to section 82(1) of the Food Standards Australia New Zealand Act 1991 (FSANZ Act), allows the Australian Pesticides and Veterinary Medicines Authority (APVMA) to vary the MRLs for agricultural and veterinary chemicals in food products. The variations include changes to the MRLs as determined by the APVMA based on assessments of these chemicals, ensuring that the residues in food do not pose a risk to public health. The changes reflect the evolving patterns of use of these chemicals, including the introduction of new products and the withdrawal of older ones. The APVMA has specific obligations under this Act to ensure that MRLs are set in a manner that safeguards public health. This involves conducting thorough assessments and determining MRLs based on residue trials and toxicological evaluations. The APVMA must also consider dietary exposure assessments to ensure that even if MRLs are exceeded, it does not present a public health concern. Furthermore, the APVMA is mandated to engage in public consultations to gather feedback on proposed MRLs before making any changes. This engagement ensures transparency and allows stakeholders to voice their concerns about the proposed amendments. In the event of non-compliance with the MRLs set forth in the amended Schedule 20, there may be significant consequences. While the Act does not explicitly detail specific offences or penalties for breaching the MRLs, non-compliance could potentially lead to legal action under broader food safety laws. Violators could face fines or other penalties as stipulated in the Food Standards Australia New Zealand Act 1991 and other relevant legislation. Additionally, non-compliance might result in the suspension or revocation of product registrations, thereby affecting the ability of manufacturers and producers to legally sell their products. These potential consequences underscore the importance of adhering to the MRLs established by the APVMA. The Instrument itself is a legislative instrument under the Legislation Act 2003 and, as such, is exempt from the disallowance and sunsetting provisions. It comes into effect on the day it is published in the Gazette, as stipulated by subsection 82(8) of the FSANZ Act. The APVMA has already published the variations in the Commonwealth of Australia Agricultural and Veterinary Chemicals Gazette, thereby ensuring that the changes are promptly and officially communicated to all relevant parties. The Instrument also includes an explanatory statement that outlines the purpose, effects, and implications of the variations, providing clarity and ensuring that all stakeholders are well-informed about the amendments.

Area of Law: Environmental Law; Food Law
Instrument: Regulation
Concepts: Commencement Provisions; Regulatory Standards; Enforcement Powers

Interactions

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.

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