
Maximum Residue Limits: Is FSANZ endorsement of Codex MRLs right or wrong? By Joe Lederman (FoodLegal Co-Principal) and John Thisgaard (FoodLegal Senior Associate) © Lawmedia Pty Ltd, May 2020 On 20 March 2020, FSANZ announced a proposal for a new process for updating Maximum Residue Limits (MRLs) for Australia in the context of harmonisation with international MRLs such as those adopted through the Codex Alimentarius Commission. This article raises concerns about the potential effect of this proposal. One of the lessons from COVID-19 is that international bodies responsible for public health and safety may be subjected to international pressures and political influence. Public health and safety in relation to what is in an imported food should be prioritised over free trade harmonisation, if there is a potential conflict or compromise required in the equation. Regulation of agricultural and veterinary MRLs Agricultural and veterinary (agvet) chemicals may be used in various food production processes, such as in fertilisers or pesticides. Agvet chemicals are monitored and regulated by the Australian Pesticides and Veterinary Medicine Authority (APVMA) through the Agricultural and Veterinary Chemicals Code Act 1994. Any agvet chemical must be assessed and approved by the APVMA before it can be sold or used in Australia. It is not uncommon for residues of such chemicals to remain on the surface of food products at the time of sale of the food product. The APVMA, in conjunction with Food Standards Australia New Zealand (FSANZ), sets maximum residue limits (MRLs) to restrict the amount of residues present and ensure foods are safe for human consumption. Schedules 20 and 21 of the Australia New Zealand Food Standards Code (Food Standards Code) set out the approved chemicals, the foods in which they can be present and the corresponding residue limits. Automatic consideration of Codex changes On 20 March 2020, FSANZ announced that it is considering whether MRLs that have been introduced into Codex Alimentarius in the immediately previous year should automatically be considered for implementation into the Food Standards Code. The intent of such a proposal is to more smoothly incorporate into Australian law any changes in international MRL levels. In order to assess how such a proposal would work, it is necessary to consider how MRLs are set at an Australian and international level. Codex Alimentarius Codex Alimentarius (Codex) is an international collection of standards, guidelines and codes of practice, jointly established by the Food and Agriculture Organization (FAO) and the World Health Organization (WHO). Codex is administered by the Codex Alimentarius Commission (CAC). A key policy objective of the CAC and the bodies responsible for food law development in various countries (including FSANZ in Australia and New Zealand) is to harmonise food regulations around the world to facilitate international trade. The CAC sets its own MRLs after establishing committees and hearing submissions from different countries. These are often used as international benchmarks and are not legally binding in themselves, but may be adopted or modified into domestic law be legislators in any country. For the purposes of many developing countries, Codex itself forms the basis of their regulation by default. Nevertheless, there are often significant environmental differences between countries, such as in the pests, diseases, environmental factors, types of foods consumed and patterns of use, which results in varied MRLs. SPS and TBT agreements Another major part of Australia’s MRL regulation is its obligations under the two international agreements, the Application of Sanitary and Phytosanitary Measures (SPS Agreement) and the Agreement on Technical Barriers to Trade (TBT Agreement). As a signatory to both agreements, Australia is obliged to take appropriate measures to protect the life and health of humans, animals and plants, and to ensure that such measures do not create unnecessary barriers to trade without arbitrary or unjustifiable discrimination. Members to these agreements are encouraged to base their own agvet MRLs on international standards and recommendations. The WTO has a notification system that alerts countries of proposed changes to a country’s MRLs, to which others can object. MRL harmonisation proposal The MRLs in Schedule 20 of the Food Standards Code can be amended in any of the following ways: via an MRL harmonisation proposal by FSANZ via an MRL application that is separate to any FSANZ proposal via an APVMA request to amend an MRL that it has recently reviewed Each year, FSANZ has initiated an annual proposal for harmonisation of Australian MRLs with those of Codex. This is in addition to individual proposals or applications in the interim between annual reviews. Up until the date of this article (May 2020), the process typically has been that FSANZ opens a call for requests from stakeholders as to which MRLs should be aligned with international standards. A food business or other interested party can specify the desired MRL and food commodity, and must provide information including the chemical properties, health-based guidance values and current legislative status of the agvet chemical, information on the commodities to be imported and evidence of any present or expected imports of the food commodity into Australia. FSANZ will then assess the safety and need for the adjusted MRL, considering whether: The residues in the food result from a legitimate use of chemical products The active ingredients are permitted for use in the country with the relevant MRL The source country has established MRLs or equivalent standards The market for the adjusted MRL and the costs to trade if no variation is made FSANZ makes a dietary exposure assessment, where it determines whether consumption of the proposed residues in the Australian context would exceed domestic or international health-based guidance limits such as the acceptable daily intake (ADI). It also does a risk assessment, opening public consultation for domestic stakeholders and international WTO members. The MRL variations that are deemed safe and appropriate are included in the MRL harmonisation proposal to be sent to the Australia New Zealand Ministerial Forum on Food Regulation (Food Forum) which will implement the legislative changes if it approves. How would the automatic consideration of Codex changes interact with this process? Under FSANZ’s 20 March 2020 proposal, FSANZ would automatically include MRLs implemented at the Codex level in the preceding 12 months as part of its yearly harmonisation proposal. For example, any MRLs introduced or amended by the CAC in 2019 would automatically be assessed for inclusion in FSANZ’s 2020 harmonisation proposal. The key difference is that FSANZ would automatically consider harmonising every Codex change to MRLs without a food business or other private party having to individually apply for the MRL to be considered by FSANZ. FSANZ has a limited budget and, unlike the US Food and Drug Administration, does not undertake extensive drill-down compositional assessments. (Incidentally, a business would still have to submit a request for FSANZ to consider any Codex MRL amendments made prior to 2019 or any international MRL changes that do not arise from Codex). Should Australians be concerned? FSANZ argues that its proposal to automatically consider MRL’s adopted at the Codex level would facilitate international harmonisation of MRL levels. Under the proposal, FSANZ would automatically consider each and every MRL adopted under Codex, rather than seeking stakeholder submissions in advance. FSANZ also says that this would relieve Australian businesses from the cost of having to gather data to make a submission. However, in reality, the role of FSANZ is to ensure that foods sold in Australia are safe. Public health must take priority over free trade if the two are to be equated. FSANZ should not deprive Australian businesses, producers and consumers of rights to query the scientific basis of an MRL determined in a Codex forum. There is a serious concern in Australia that some countries potentially could export products with higher pesticide and herbicide residue levels than has been the acceptable level in Australia. It would be strange for the Australian government’s food standard-setting body to be so open to the idea of accepting a Codex MRL by default when the Codex process is open to strong political influences or interference by different national interests. If the COVID-19 pandemic has taught Australians anything, one of the lessons to be learned is that international bodies such as the WHO are not impervious to political influence or policy pressures exerted by any one country. The argument for free trade and movement of people or goods must be tempered by the prioritisation of the need for public health and safety in Australia. FSANZ’s call for submissions in relation to the 2020 MRL harmonisation proposal is currently open until 6pm 15 May 2020. This is general information rather than legal advice and is current as of 6 May 2020. We therefore recommend you seek legal advice for your particular circumstances if you want to rely on advice or information to be a basis for any commercial decision-making by you or your business.

Maximum Residue Limits: Is FSANZ endorsement of Codex MRLs right or wrong?

By Joe Lederman (FoodLegal Co-Principal) and John Thisgaard (FoodLegal Senior Associate)

On 20 March 2020, FSANZ announced a proposal for a new process for updating Maximum Residue Limits (MRLs) for Australia in the context of harmonisation with international MRLs such as those adopted through the Codex Alimentarius Commission.

This article raises concerns about the potential effect of this proposal. One of the lessons from COVID-19 is that international bodies responsible for public health and safety may be subjected to international pressures and political influence.

Public health and safety in relation to what is in an imported food should be prioritised over free trade harmonisation, if there is a potential conflict or compromise required in the equation.

Regulation of agricultural and veterinary MRLs

Agricultural and veterinary (agvet) chemicals may be used in various food production processes, such as in fertilisers or pesticides. Agvet chemicals are monitored and regulated by the Australian Pesticides and Veterinary Medicine Authority (APVMA) through the Agricultural and Veterinary Chemicals Code Act 1994. Any agvet chemical must be assessed and approved by the APVMA before it can be sold or used in Australia.

It is not uncommon for residues of such chemicals to remain on the surface of food products at the time of sale of the food product. The APVMA, in conjunction with Food Standards Australia New Zealand (FSANZ), sets maximum residue limits (MRLs) to restrict the amount of residues present and ensure foods are safe for human consumption. Schedules 20 and 21 of the Australia New Zealand Food Standards Code (Food Standards Code) set out the approved chemicals, the foods in which they can be present and the corresponding residue limits.

Automatic consideration of Codex changes

On 20 March 2020, FSANZ announced that it is considering whether MRLs that have been introduced into Codex Alimentarius in the immediately previous year should automatically be considered for implementation into the Food Standards Code. The intent of such a proposal is to more smoothly incorporate into Australian law any changes in international MRL levels.

In order to assess how such a proposal would work, it is necessary to consider how MRLs are set at an Australian and international level.

Codex Alimentarius

Codex Alimentarius (Codex) is an international collection of standards, guidelines and codes of practice, jointly established by the Food and Agriculture Organization (FAO) and the World Health Organization (WHO). Codex is administered by the Codex Alimentarius Commission (CAC). A key policy objective of the CAC and the bodies responsible for food law development in various countries (including FSANZ in Australia and New Zealand) is to harmonise food regulations around the world to facilitate international trade.

The CAC sets its own MRLs after establishing committees and hearing submissions from different countries. These are often used as international benchmarks and are not legally binding in themselves, but may be adopted or modified into domestic law be legislators in any country. For the purposes of many developing countries, Codex itself forms the basis of their regulation by default.

Nevertheless, there are often significant environmental differences between countries, such as in the pests, diseases, environmental factors, types of foods consumed and patterns of use, which results in varied MRLs.

SPS and TBT agreements

Another major part of Australia’s MRL regulation is its obligations under the two international agreements, the Application of Sanitary and Phytosanitary Measures (SPS Agreement) and the Agreement on Technical Barriers to Trade (TBT Agreement). As a signatory to both agreements, Australia is obliged to take appropriate measures to protect the life and health of humans, animals and plants, and to ensure that such measures do not create unnecessary barriers to trade without arbitrary or unjustifiable discrimination.

Members to these agreements are encouraged to base their own agvet MRLs on international standards and recommendations. The WTO has a notification system that alerts countries of proposed changes to a country’s MRLs, to which others can object.

MRL harmonisation proposal

The MRLs in Schedule 20 of the Food Standards Code can be amended in any of the following ways:

via an MRL harmonisation proposal by FSANZ
via an MRL application that is separate to any FSANZ proposal
via an APVMA request to amend an MRL that it has recently reviewed

Each year, FSANZ has initiated an annual proposal for harmonisation of Australian MRLs with those of Codex. This is in addition to individual proposals or applications in the interim between annual reviews. Up until the date of this article (May 2020), the process typically has been that FSANZ opens a call for requests from stakeholders as to which MRLs should be aligned with international standards. A food business or other interested party can specify the desired MRL and food commodity, and must provide information including the chemical properties, health-based guidance values and current legislative status of the agvet chemical, information on the commodities to be imported and evidence of any present or expected imports of the food commodity into Australia.

FSANZ will then assess the safety and need for the adjusted MRL, considering whether:

The residues in the food result from a legitimate use of chemical products
The active ingredients are permitted for use in the country with the relevant MRL
The source country has established MRLs or equivalent standards
The market for the adjusted MRL and the costs to trade if no variation is made

FSANZ makes a dietary exposure assessment, where it determines whether consumption of the proposed residues in the Australian context would exceed domestic or international health-based guidance limits such as the acceptable daily intake (ADI). It also does a risk assessment, opening public consultation for domestic stakeholders and international WTO members.

The MRL variations that are deemed safe and appropriate are included in the MRL harmonisation proposal to be sent to the Australia New Zealand Ministerial Forum on Food Regulation (Food Forum) which will implement the legislative changes if it approves.

How would the automatic consideration of Codex changes interact with this process?

Under FSANZ’s 20 March 2020 proposal, FSANZ would automatically include MRLs implemented at the Codex level in the preceding 12 months as part of its yearly harmonisation proposal. For example, any MRLs introduced or amended by the CAC in 2019 would automatically be assessed for inclusion in FSANZ’s 2020 harmonisation proposal.

The key difference is that FSANZ would automatically consider harmonising every Codex change to MRLs without a food business or other private party having to individually apply for the MRL to be considered by FSANZ. FSANZ has a limited budget and, unlike the US Food and Drug Administration, does not undertake extensive drill-down compositional assessments.

(Incidentally, a business would still have to submit a request for FSANZ to consider any Codex MRL amendments made prior to 2019 or any international MRL changes that do not arise from Codex).

Should Australians be concerned?

FSANZ argues that its proposal to automatically consider MRL’s adopted at the Codex level would facilitate international harmonisation of MRL levels. Under the proposal, FSANZ would automatically consider each and every MRL adopted under Codex, rather than seeking stakeholder submissions in advance.

FSANZ also says that this would relieve Australian businesses from the cost of having to gather data to make a submission.

However, in reality, the role of FSANZ is to ensure that foods sold in Australia are safe. Public health must take priority over free trade if the two are to be equated.

FSANZ should not deprive Australian businesses, producers and consumers of rights to query the scientific basis of an MRL determined in a Codex forum.

There is a serious concern in Australia that some countries potentially could export products with higher pesticide and herbicide residue levels than has been the acceptable level in Australia.

It would be strange for the Australian government’s food standard-setting body to be so open to the idea of accepting a Codex MRL by default when the Codex process is open to strong political influences or interference by different national interests.

If the COVID-19 pandemic has taught Australians anything, one of the lessons to be learned is that international bodies such as the WHO are not impervious to political influence or policy pressures exerted by any one country. The argument for free trade and movement of people or goods must be tempered by the prioritisation of the need for public health and safety in Australia.

FSANZ’s call for submissions in relation to the 2020 MRL harmonisation proposal is currently open until 6pm 15 May 2020.

This is general information rather than legal advice and is current as of 6 May 2020. We therefore recommend you seek legal advice for your particular circumstances if you want to rely on advice or information to be a basis for any commercial decision-making by you or your business.