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Australia New Zealand Food Standards Code — Standard 1.4.2 — Maximum Residue Limits Amendment Instrument No. APVMA 3, 2015

Australia New Zealand Food Standards Code — Standard 1.4.2 — Maximum Residue Limits Amendment Instrument No. APVMA 3, 2015

Administered by Department of Health, Disability and Ageing

Legislation au F2015L00638 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

Australia New Zealand Food Standards Code—

Standard 1.4.2—Maximum Residue Limits

Amendment Instrument No. APVMA 3, 2015

Subsection 82(1) of the Food Standards Australia New Zealand Act 1991 provides that the Australian Pesticides and Veterinary Medicines Authority (APVMA) may vary Schedule 1 of 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 Standard 1.4.2 — Maximum Residue Limits.

Standard 1.4.2 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 Standard 1.4.2.

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.

Subsection 11(1) of the Agricultural and Veterinary Chemicals (Administration) Act 1992 provides that the APVMA may, by writing under its common seal, delegate to a member of the staff of the APVMA all or any of its powers. By written instrument under the seal of the APVMA of 7 June 2011, the APVMA has delegated to the holder of the office of Executive Director, Scientific Assessment and Chemical Review its powers under subsection 82(1) of the Food Standards Australia New Zealand Act 1991.

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 1 of Standard 1.4.2 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 1 of Standard 1.4.2 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 3) on 10 February 2015 the APVMA notified that it was proposing to incorporate these variations to MRLs into Standard 1.4.2 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 Standard 1.4.2 and no comment was received in response to that notice.

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 Legislative Instruments 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 — Standard 1.4.2 — Maximum Residue Limits Amendment Instrument No. APVMA 3, 2015.

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 Legislative Instruments Act 2003, a legislative instrument made by the APVMA varying Standard 1.4.2 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 9 of 5 May 2015.

Item 3 Object

4. This item provides that the object of this Amendment Instrument is for the APVMA to vary Schedule 1 of Standard 1.4.2 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 Standard 1.4.2 — 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 the whole of the Australia New Zealand Food Standard Code (including Standard 1.4.2) was further published in Gazette P 30 of 20 December 2000. This was specifically included as the amendment history at the beginning of the Food Standards Code dates only from that time.

Item 5 Variations to Standard 1.4.2

9. This item provides that the Schedule to this Amendment Instrument sets out the variations to Standard 1.4.2 – 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 January 2015 comprising amendments numbered (Agricultural and Veterinary Chemicals Code Instrument No. 4 (MRL Standard) Amendment Instrument 2015 (No. 1)) inclusive.

By Authority:

Executive Director, Scientific Assessment and Chemical Review

Delegate of the APVMA

28 April 2015

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

Overview

The Australia New Zealand Food Standards Code—Standard 1.4.2—Maximum Residue Limits Amendment Instrument No. APVMA 3, 2015 was enacted to address the need for streamlining regulatory processes and eliminating duplication in setting maximum residue limits (MRLs) for agricultural and veterinary chemical products in food. This instrument was introduced in response to a 2008 reform agreed to by the Council of Australian Governments (COAG) that sought to recognise the Australian Pesticides and Veterinary Medicines Authority’s (APVMA) residue risk assessments and to allow the APVMA to directly vary the MRLs in the Food Standards Code. The APVMA, an independent statutory authority of the Commonwealth, is responsible for ensuring that agricultural and veterinary chemicals used in Australia do not pose a risk to public health through residues in food. The policy objective of this amendment is to incorporate variations to MRLs into the Food Standards Code, thereby allowing the sale of food containing residues that do not exceed the set limits, as determined by the APVMA. The APVMA has delegated its powers under the Food Standards Australia New Zealand Act 1991 to the holder of the office of Executive Director, Scientific Assessment and Chemical Review. This legislative instrument, published in the Gazette, does not require a Regulatory Impact Statement and does not fall under the disallowance or sunsetting provisions of the Legislative Instruments Act 2003.

Scope and Application

The Australia New Zealand Food Standards Code—Standard 1.4.2—Maximum Residue Limits Amendment Instrument No. APVMA 3, 2015 applies to the Australian Pesticides and Veterinary Medicines Authority (APVMA), which is an independent statutory authority of the Commonwealth, and to the agricultural and veterinary chemicals used in Australia. This legislation enables the APVMA to directly vary the maximum residue limits (MRLs) of agricultural and veterinary chemicals in food products within the Australia New Zealand Food Standards Code (Food Standards Code). This amendment facilitates the streamlining of regulatory processes and the elimination of duplication by allowing the APVMA to incorporate its residue risk assessments directly into the Food Standards Code. The scope of this Act extends to all agricultural and veterinary chemical products used within Australia and listed in Schedule 1 of the Food Standards Code. The MRLs set forth in this amendment ensure the safe consumption of food products by establishing the maximum allowable levels of chemical residues, which do not normally indicate a public health or safety concern. The variations to MRLs are legislative instruments and are not subject to the disallowance or sunsetting provisions. The APVMA, through public consultation and notification to the World Trade Organization, seeks the wider community's involvement in its evaluation process for the registration of new agricultural and veterinary chemical products or a major extension of the use of existing products to new crops and target animals. The Act applies across the Commonwealth of Australia and is not restricted to any particular state, territory, or jurisdiction. The APVMA has the power to delegate its authority to the holder of the office of Executive Director, Scientific Assessment and Chemical Review. The variations to MRLs made by the Amendment Instrument are minor, technical changes to the Food Standards Code and do not require a Regulatory Impact Statement. The APVMA's assessment of the safety and performance of agricultural and veterinary chemicals includes the determination of an MRL for the chemical in relation to relevant crops and animals. The variations to MRLs in this amendment are a consequence of the APVMA's decision to register agricultural and veterinary chemical products, vary and extend their approved label instructions, or withdraw or restrict older products following review. The variations to MRLs are intended to reflect changing use patterns of agricultural and veterinary chemicals and do not present any public health and safety concerns.

Key Provisions

The main operative sections of this Amendment Instrument pertain to the Australian Pesticides and Veterinary Medicines Authority’s (APVMA) power to vary the maximum residue limits (MRLs) for agricultural and veterinary chemicals in food. Specifically, subsection 82(1) of the Food Standards Australia New Zealand Act 1991 (FSANZ Act) allows the APVMA to vary Schedule 1 of Standard 1.4.2 — Maximum Residue Limits in the Australia New Zealand Food Standards Code. This Amendment Instrument, numbered APVMA 3, 2015, exercises this power to update the MRLs listed in Schedule 1 of Standard 1.4.2. These MRLs are regulatory standards that ensure the safe use of agricultural and veterinary chemicals by setting the maximum levels of chemical residues that can legally remain in food products. The obligations imposed by this Amendment Instrument on the parties it governs are primarily focused on ensuring compliance with the updated MRLs. The APVMA is tasked with setting and monitoring these MRLs to safeguard public health. Primary producers and food processors must ensure that their use of agricultural and veterinary chemicals complies with the approved label instructions, which are aligned with the MRLs set by the APVMA. By incorporating these MRLs into the Food Standards Code, the Amendment Instrument establishes a legal framework within which food containing chemical residues, provided they do not exceed the MRLs, can be sold. Breaching the provisions of this Amendment Instrument can lead to several consequences. If residues of agricultural and veterinary chemicals in food exceed the established MRLs, it may indicate misuse of the chemicals. Although this typically does not pose a direct public health concern, it could lead to legal action under food safety regulations. The APVMA has the authority to take enforcement actions against non-compliance, which may include fines or other penalties as stipulated under the Agricultural and Veterinary Chemicals (Administration) Act 1992. The exact penalties for breaches are determined by the relevant state or territory legislation, but they generally aim to ensure that food products remain safe for consumption and that the use of agricultural and veterinary chemicals is properly regulated.

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