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Australia New Zealand Food Standards Code — Schedule 20 – Maximum residue limits Variation Instrument No. APVMA 9, 2016

Australia New Zealand Food Standards Code — Schedule 20 – Maximum residue limits Variation Instrument No. APVMA 9, 2016

Administered by Department of Health, Disability and Ageing

Legislation au F2016L01579 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 9, 2016

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 13) on 28 June 2016 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. 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 9, 2016.

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 20 of 4 October 2016.

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 July 2016 comprising amendments numbered (Agricultural and Veterinary Chemicals Code Instrument No. 4 (MRL Standard) Amendment Instrument 2016 (No. 8)) 28 June 2016 inclusive.

By Authority:

Chief Executive Officer

Delegate of the APVMA

27 September 2016

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 9, 2016 was enacted in 2016 to address the need for streamlined regulatory processes and to eliminate duplication by allowing the Australian Pesticides and Veterinary Medicines Authority (APVMA) to directly vary the Maximum Residue Limits (MRL) Standard in the Australia New Zealand Food Standards Code. This Instrument was developed under the authority of subsection 82(1) of the Food Standards Australia New Zealand Act 1991, with the policy objective of ensuring that agricultural and veterinary (agvet) chemicals used in Australia do not pose a risk to public health due to residues in food. The APVMA, as an independent statutory authority of the Commonwealth, is responsible for assessing and determining MRLs for agvet chemicals to ensure they are safe for consumption when used as directed. The variations to MRLs incorporated in this Instrument are a direct result of the APVMA’s assessment and determination process, reflecting changes in the use patterns of agvet chemicals. These amendments are designed to benefit primary producers and consumers by allowing the sale of food containing legitimate residues that do not exceed the MRLs set by the APVMA.

Scope and Application

The Australia New Zealand Food Standards Code—Schedule 20—Maximum Residue Limits Variation Instrument No. APVMA 9, 2016, operates under the authority granted by the Food Standards Australia New Zealand Act 1991. This legislation applies to the Australian Pesticides and Veterinary Medicines Authority (APVMA), which is an independent statutory authority responsible for ensuring that agricultural and veterinary chemicals used in Australia are safe and do not pose a risk to public health through chemical residues in food. The APVMA is tasked with varying the Maximum Residue Limits (MRLs) as listed in Schedule 20 of the Food Standards Code, which pertains to the maximum allowable levels of chemical residues in food products. This legislation pertains to the entire Commonwealth of Australia and is integral to regulating the agricultural and veterinary chemical industry. It does not extend to New Zealand, as MRLs for residues of agricultural and veterinary chemicals in food are independently developed by each country under their respective regulatory frameworks. The variations made to the MRLs in Schedule 20 are legislative instruments under the Legislation Act 2003 and are not subject to disallowance or sunsetting provisions. These variations are a direct consequence of the APVMA's assessment and determination processes for the safety and efficacy of agricultural and veterinary chemicals, ensuring that residues in food do not present any public health or safety concerns.

Key Provisions

The key provisions of the Australia New Zealand Food Standards Code—Schedule 20—Maximum Residue Limits Variation Instrument No. APVMA 9, 2016 (Amendment Instrument) primarily focus on updating the Maximum Residue Limits (MRL) Standard in the Food Standards Code. Under Section 82(1) of the Food Standards Australia New Zealand Act 1991, the Australian Pesticides and Veterinary Medicines Authority (APVMA) is empowered to vary the MRL Standard to include or change permitted maximum residue limits. Schedule 20 of the Food Standards Code, which lists the maximum levels of residues of agricultural and veterinary (agvet) chemicals that may occur in foods, is the principal instrument being amended. This amendment allows the sale of food containing legitimate residues, provided they do not exceed these limits, and ensures the standards reflect current use patterns of agvet chemicals. The Amendment Instrument imposes several obligations on the APVMA and other relevant entities. Firstly, the APVMA must assess and determine MRLs for agvet chemicals based on data from residue trials, ensuring that the application of the minimum amount of chemical required for effective pest or disease control will not leave unsafe residues in plant or animal commodities. The APVMA must also conduct toxicological evaluations and dietary exposure assessments to ensure that MRL variations do not present any public health or safety concerns. These assessments are integral to the regulatory process for approving or varying the use of agvet chemicals in Australia. The APVMA must also engage in public consultations as part of its evaluation process for the registration of new agvet chemical products or significant extensions of existing products to new crops and target animals. This ensures that the wider community has the opportunity to comment on or raise concerns about the proposed MRLs and dietary exposure assessments. Failure to comply with the MRLs set forth in the Food Standards Code could result in significant legal consequences. Although the Amendment Instrument does not explicitly list specific offences, penalties, or civil/criminal consequences for breach, non-compliance with MRLs could lead to the prohibition of the sale of food products containing unsafe chemical residues, thereby impacting businesses and potentially leading to regulatory action. The APVMA is responsible for ensuring that agvet chemicals do not pose harm to public health due to residues in food, and any breach of these standards could result in enforcement actions by the APVMA or other relevant authorities. The Amendment Instrument itself is a legislative instrument under the Legislation Act 2003, but it is neither subject to the disallowance nor the sunsetting provisions. The variations to the MRLs made by the Amendment Instrument are integral to maintaining the safety and integrity of the food supply by ensuring that residues of agvet chemicals in food do not exceed safe limits. The APVMA’s role in assessing and determining these limits, coupled with the requirement for public consultation, ensures a transparent and rigorous process for updating MRLs in the Food Standards Code. By incorporating these variations into Schedule 20, the Amendment Instrument aims to streamline regulatory processes and eliminate duplication, ultimately benefiting both primary producers and consumers by ensuring the safety and legality of food products containing permissible chemical residues.

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

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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.

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