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Australia New Zealand Food Standards Code — Schedule 20 – Maximum residue limits Variation Instrument No. APVMA 11, 2017

Australia New Zealand Food Standards Code — Schedule 20 – Maximum residue limits Variation Instrument No. APVMA 11, 2017

Administered by Department of Health, Disability and Ageing

Legislation au F2017L01404 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 11, 2017

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 16) on 16 August 2017 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.

FSANZ also made Sanitary and Phytosanitary notification to the World Trade Organization (WTO) in relation to the variations to MRLs in Schedule 20 and comment was received in response to that notice 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 11, 2017.

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 Gazette No. APVMA 22 of 31 October 2017.

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 August 2017 comprising amendments numbered (Agricultural and Veterinary Chemicals Code Instrument No. 4 (MRL Standard) Amendment Instrument 2016 (No. 8)) inclusive.

By Authority:

Chief Executive Officer

Delegate of the APVMA

25 October 2017

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 11, 2017 was enacted to address the need for streamlined regulatory processes concerning Maximum Residue Limits (MRLs) for agricultural and veterinary (agvet) chemicals in food, as part of the broader reform agreed to by the Council of Australian Governments (COAG) in 2008. This legislative instrument, introduced by the Australian Pesticides and Veterinary Medicines Authority (APVMA), an independent statutory authority under the Commonwealth, aims to incorporate MRL variations into the Food Standards Code to ensure that residues of agvet chemicals in food do not pose any public health and safety concerns. By recognising the APVMA's residue risk assessment and allowing it to directly vary MRLs, this instrument seeks to eliminate duplication and enhance efficiency in the regulatory framework. The policy objective is to facilitate the lawful sale of food containing residues that do not exceed the MRLs established by the APVMA, thereby benefiting primary producers and consumers.

Scope and Application

The Australia New Zealand Food Standards Code — Schedule 20 — Maximum Residue Limits Variation Instrument No. APVMA 11, 2017, applies to the Australian Pesticides and Veterinary Medicines Authority (APVMA) and the regulated entities within its jurisdiction. The APVMA is an independent statutory authority responsible for ensuring that agricultural and veterinary chemicals used in Australia do not pose a risk to public health due to residues in food. The Act applies to the determination of Maximum Residue Limits (MRLs) for these chemicals, which are the maximum levels of residues that can legally be present in food products. These MRLs are established to monitor that the chemicals are used according to approved label instructions and to ensure that any residues in food do not exceed levels that could pose a risk to public health. The scope of this legislation is national, as it pertains to the regulation of chemicals used across Australia, impacting various industries, including agriculture and food production. The MRLs set by the APVMA are incorporated into Schedule 20 of the Food Standards Code, thereby influencing the legal sale of food products containing residues within permissible limits. The instrument does not specify exclusions, exemptions, or thresholds within its primary text but references the MRL Standard maintained by the APVMA, which includes the necessary technical details and variations. The variations to MRLs are legislative instruments that, while subject to the Legislation Act 2003, are exempt from disallowance and sunsetting provisions. The APVMA makes these variations as a direct consequence of its regulatory decisions regarding the registration, use, and review of agricultural and veterinary chemical products, and they are published in the Gazette upon effectuation. This legislative framework ensures that any changes to MRLs are science-based and communicated transparently to the public, facilitating compliance and safety in the use of these chemicals.

Key Provisions

The main operative sections of this legislation, specifically the Australia New Zealand Food Standards Code—Schedule 20—Maximum Residue Limits Variation Instrument No. APVMA 11, 2017, focus on the amendments to the Maximum Residue Limits (MRLs) as outlined in Schedule 20 of the Food Standards Code. This Amendment Instrument, as stated in section 1, allows the Australian Pesticides and Veterinary Medicines Authority (APVMA) to include or alter permitted MRLs for agricultural and veterinary (agvet) chemicals in food. These MRLs, detailed in section 5, are maximum levels of residues of agvet chemicals that can occur in food, thereby ensuring that any residues present in food do not exceed these limits, which is crucial for public health and safety. The variations made by the APVMA are science-based outcomes resulting from decisions to register new agvet chemical products, extend their approved label instructions, or review and withdraw older products, as noted in section 9. The obligations imposed on parties governed by this Act include ensuring compliance with the MRLs set by the APVMA. Specifically, section 82(1) of the Food Standards Australia New Zealand Act 1991 mandates that the APVMA must evaluate the safety and performance of agvet chemicals, determine appropriate MRLs, and incorporate these into the Food Standards Code. This ensures that the use of agvet chemicals does not result in residues exceeding the established limits, thus safeguarding food safety. Additionally, section 5 outlines the APVMA's responsibility to conduct public consultations, inviting comments and concerns from the community regarding the registration and use of agvet chemicals, including proposed MRLs. Section 2 of the legislation details that variations to MRLs made by the APVMA are legislative instruments under the Legislation Act 2003, and they commence on the day they are published in the Gazette. This means that once the APVMA proposes changes to MRLs, these changes take effect immediately upon publication. The APVMA has already published the variations in Gazette No. APVMA 22 on 31 October 2017. The APVMA also seeks community involvement and feedback through public consultations, which is critical for ensuring transparency and public trust in the regulatory process. Offences and penalties for breaches of this legislation are not explicitly detailed within the provided text. However, as variations to MRLs are incorporated into the Food Standards Code, non-compliance with these standards could potentially result in legal consequences. This might include actions taken against individuals or entities that produce food containing residues exceeding the established MRLs, which could lead to fines or other penalties under related food safety and quality laws. The exact penalties would depend on the specific legislation under which enforcement actions are taken, such as the Food Standards Australia New Zealand Act 1991 or other relevant state and territory laws.

Area of Law: Environmental Law; Food Law
Instrument: Legislative Instrument
Concepts: Definitions & Interpretation; Regulatory Standards; Enforcement Powers; Compliance Obligations

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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