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Australia New Zealand Food Standards Code — Standard 1.4.2 — Maximum Residue Limits Amendment Instrument No. APVMA 4, 2013

Australia New Zealand Food Standards Code — Standard 1.4.2 — Maximum Residue Limits Amendment Instrument No. APVMA 4, 2013

Administered by Department of Health, Disability and Ageing

Legislation au F2013L01498 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 4, 2013

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 Program Manager, Pesticides Program 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 www.apvma.gov.au/residues/standard.php).

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 10) on 21 May 2013 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 4, 2013.

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 16 of 13 August 2013.

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 May 2013 comprising amendments Agricultural and Veterinary Chemicals Code Instrument No. 4 (MRL Standard) Amendment Instrument 2013 (No. 2) inclusive.

By Authority:

Program Manager, Pesticides Program

Delegate of the APVMA

30 July 2013

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 4, 2013 was enacted in 2013 to facilitate the incorporation of maximum residue limits (MRLs) for agricultural and veterinary chemicals into the Australia New Zealand Food Standards Code. This amendment was introduced to streamline regulatory processes and eliminate duplication by enabling the Australian Pesticides and Veterinary Medicines Authority (APVMA) to directly vary MRLs in the Food Standards Code. The APVMA, an independent statutory authority responsible for ensuring that agricultural and veterinary chemicals used in Australia do not harm public health due to residues in food, was given the authority to vary Schedule 1 of Standard 1.4.2 under the Food Standards Australia New Zealand Act 1991. This amendment was designed to ensure that MRLs, which are regulatory standards for monitoring the use of agricultural and veterinary chemicals, are included in the Food Standards Code, thus legitimising the presence of these residues and allowing the sale of food containing residues that do not exceed the set limits. The APVMA's assessment of the safety and performance of these chemicals includes determining appropriate MRLs for relevant crops and animals, with the objective of protecting public health and safety. The enactment of this Amendment Instrument by the APVMA was based on the need to incorporate technical variations into the Food Standards Code, reflecting changes in the use patterns of agricultural and veterinary chemicals. These changes include the development of new products and crop uses, as well as the withdrawal of older products following review by the APVMA. The regulatory impact assessment indicated that the proposed changes were minor and machinery in nature, with negligible impacts on business, individuals, regulatory agencies, or the economy. The APVMA consulted with the wider community during the evaluation process for the registration of new agricultural and veterinary chemical products and invited public comment on the proposed MRL variations, although no comments were received. This amendment instrument is a legislative instrument under the Legislative Instruments Act 2003, but it is not subject to the disallowance or sunsetting provisions.

Scope and Application

The Australia New Zealand Food Standards Code—Standard 1.4.2—Maximum Residue Limits Amendment Instrument No. APVMA 4, 2013 applies to the Australian Pesticides and Veterinary Medicines Authority (APVMA) and agricultural and veterinary (agvet) chemical products used in Australia. The APVMA, as an independent statutory authority of the Commonwealth, is responsible for ensuring that agvet chemicals used in Australia are not harmful to public health due to residues in food. This instrument amends the Maximum Residue Limits Standard in the Food Standards Code by varying Schedule 1 to include or change permitted maximum residue limits for agvet chemical products. The changes are a direct consequence of the APVMA's assessment and determination of MRLs, which are regulatory standards to monitor the use of agvet chemicals in accordance with approved label instructions. The variations to MRLs in the Food Standards Code are a legislative instrument under the Legislative Instruments Act 2003, and they do not require disallowance or sunsetting provisions. The APVMA has delegated its powers under the Food Standards Australia New Zealand Act 1991 to the Program Manager, Pesticides Program, who is responsible for implementing the changes to the MRL Standard. The scope of this legislation is national, applying across all states and territories of Australia. It does not apply to New Zealand as 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 joint food standards system. Australia and New Zealand independently and separately develop MRLs for agvet chemicals in food. The variations to MRLs made by the Amendment Instrument do not present any public health and safety concerns, as determined by the APVMA through its toxicological evaluation and dietary exposure assessment. The changes are minor and technical, and they are an essential consequence of the APVMA's decision to register agvet chemical products, vary and extend their approved label instructions, or to issue a permit in relation to an agvet chemical product. The incorporation of APVMA approved MRLs into Schedule 1 of Standard 1.4.2 of the Food Standards Code benefits primary producers and consumers by allowing the sale of food containing legitimate residues, where any residues do not exceed the MRL.

Key Provisions

The main operative sections of this Amendment Instrument, as outlined in the explanatory statement, involve variations to Standard 1.4.2 of the Australia New Zealand Food Standards Code, which pertains to maximum residue limits (MRLs) for agricultural and veterinary (agvet) chemicals in food. This is done through the APVMA (Australian Pesticides and Veterinary Medicines Authority) varying Schedule 1 of Standard 1.4.2, as permitted by subsection 82(1) of the Food Standards Australia New Zealand Act 1991 (subsection 82(1)). The variations in MRLs reflect changes in the use patterns of agvet chemicals and the registration, extension, or withdrawal of chemical products by the APVMA. These variations are intended to ensure that the use of agvet chemicals does not pose any public health or safety concerns. The Amendment Instrument imposes specific obligations on the APVMA and other relevant parties. The APVMA is responsible for assessing the safety and performance of agvet chemicals, including determining appropriate MRLs based on residue trials and dietary exposure assessments. It must ensure that any residues in food do not exceed the established MRLs and that the variations to these limits do not present public health and safety concerns. The APVMA also engages in public consultation during the evaluation process for new or extended use of agvet chemical products. The public is invited to comment on the proposed MRLs and other relevant aspects of the chemical products. Breaches of the provisions in the Amendment Instrument can lead to various civil and criminal consequences. If a food product is found to contain residues exceeding the established MRLs, it may be considered non-compliant with the Food Standards Code, leading to potential legal action against the producer or distributor. The APVMA may take enforcement actions against those who misuse agvet chemicals, resulting in residues that exceed the MRLs. While the explanatory statement does not specify penalties, breaches of food standards and regulations in Australia can result in fines and other legal penalties. The exact penalties depend on the severity of the breach and are determined by the relevant authorities. The variations to MRLs made by this Amendment Instrument are legislative instruments under the Legislative Instruments Act 2003 (subsection 82(2)). They are not subject to the disallowance or sunsetting provisions, meaning they do not require parliamentary approval to commence and remain in effect unless otherwise repealed. The variations to MRLs are incorporated into Schedule 1 of Standard 1.4.2 of the Food Standards Code, ensuring that the sale of food containing residues within the approved limits is lawful.

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

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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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