Chemical Regulation
Australia
Agricultural and veterinary chemicals in Australia are generally referred to as “agvet” chemicals.
For an agvet chemical product to legally be manufactured, imported, supplied, sold or used in Australia, it must be registered by the Australian Pesticides and Veterinary Medicines Authority (APVMA), unless exempt by the Agvet Code.
Agvet chemicals in Australia are regulated through a cooperative National Registration Scheme. The scheme operates through the Commonwealth and the States and Territories, with each party having differing responsibilities:
- APVMA – is responsible for assessment and registration of all agvet chemicals, as well as control of supply activities (for example, retail sale).
- FSANZ – Food Standards Australia New Zealand is responsible for developing food standards for Australia and New Zealand.
- States and Territories – are responsible for regulating the control of agvet chemical use after supply.
For further reading please refer to here.
In 2019 a first principles review of the agvet chemical regulatory framework commenced. This review will impact a range of stakeholders and take some time to complete. For further reading refer to here.
a) Australian Pesticides and Veterinary Medicines Authority (APVMA)
The APVMA operates as per requirements under various government Acts and subordinate Regulations. As noted above, there is currently a review and changes being made to those Acts and Regulations (legislation) to make them more flexible and simpler to manage, while still maintaining the rigour required in chemical regulation.
The APVMA uses independent, expert scientific advice to inform and guide the regulatory decisions they make.
In summary, amongst other things the APVMA:
- Approves active constituents in agvet chemical products.
- Registers agvet chemical products. That approval includes a range of information and requirements to be followed, including packaging, labelling with all necessary limitations, precautions and directions for use.
- Only registers Agvet chemical products that are safe for people and the environment and can effectively control pests and diseases on animals and plants (i.e., efficacious). This ensures that users and consumers have access to safe and effective chemicals and provided they are used as per label directions, any residues arising on food are considered to be safe.
- May set a maximum residue limit (MRL) for both food (table 1) and feed (table 4) when registering that chemical / commodity combination as approved for use in Australia.
- Develops and maintains a list of
- commodity portions to which MRLs apply (table 2)
- residue definitions to which MRLs as assessed/apply (table 3)
- compounds/chemicals where MRLs are not necessary to be set (table 5)
- Monitors and enforces compliance with the relevant legislation.
- Maintains a Record and Register of approved agvet constituents, registered products and approved labels for all agvet chemicals. To review a registered label refer to a list of registered chemical products on the APVMA PubCRIS.
- In certain situations allow for the legal use of chemical products in ways different from the uses set out on the chemical product label. They may also issue a permit allowing the use of a particular agvet chemical product in a limited way (that is, for minor uses, emergency uses or research purposes).
- Consults with all industry and general stakeholders on a range of matters, including proposed registration of new chemicals, changes to label directions and changes to MRLs.
For detailed information on the above and other activities of the APVMA refer to:
APVMA MRLs for food (Table 1) and feed (table 4)
To sign up to receive APVMA news and updates
For a brief overview on information contained in the links above, click here.
b) Food Standards Australia New Zealand (FSANZ)
Amongst other things FSANZ:
- Is responsible for developing the Food Standards Code (Code).
- In relation to chemicals, the Code sets out the maximum residue limits (MRLs) in food sold for sale within Australia, whether that food is produced domestically or imported (refer Standard 1.4.2 of the Food Standards Code & Schedule 20).
- FSANZ, together with the APVMA, perform dietary risk assessments when new MRLs are proposed to determine that agvet chemical residues in the Australian diet should not result in a food safety concern.
- FSANZ also considers how to harmonise Australian MRLs with international limits where possible (i.e., if usage patterns of a chemical are the same). FSANZ generally prepares one MRL proposal each year to consider requests to harmonise those MRLs.
- FSANZ analyses chemical residues in Australian food through the Australian Total Diet Study.
- Has a process to manage low-level agricultural and veterinary chemicals without MRLs. This process is generally called “Managing Low-level Ag & Vet Chemicals without MRLs”:
- Current food regulatory requirements specify there must be no detectable residue of an agvet chemical in a food commodity (zero tolerance) if there is no established MRL in Schedule 20 for the particular agvet chemical/ food combination.
- However, even with good agricultural practice, due to spray drift or crop rotation, agvet chemical residues can inadvertently occur in foods that have no associated MRLs.
- The absence of MRLs for these foods means they cannot legally be sold even if there are no public health and safety concerns.
- The ‘zero tolerance’ approach has caused concerns for primary food producers and enforcement agencies.
- Following a review and approval process, FSANZ will develop an “All other foods except animal food commodities MRLs”.
- These MRLs apply only within Australia.
For more detailed information on the above and other activities of FSANZ refer to:
For a brief overview on information contained in the links above, click here
c) States and Territories
States and Territories are responsible for a number of aspects relating to chemicals including but not limited to:
- Managing the use of chemicals beyond the point of retail sale. In some jurisdictions, more than one agency is involved.
- Investigations into mis-use of chemicals and non-compliance with MRLs.
For a list of the various State and Territory government agencies responsible for managing the use of pesticides and veterinary medicines see https://apvma.gov.au/node/3190
As with APVMA legislation, States and Territories are responsible for monitoring and enforcing the Food Standards Code including those MRLs. States and Territories also undertake surveillance programs for agvet chemical residues in food and also monitor the use of agvet chemicals by food producers.
See also Technical Guideline Document No.15 Managing Chemical Violations for actions industry should also implement when an MRL violation has been detected.
National Residue Survey
The National Residue Survey (NRS) is not a regulator but is an operational section of the DAWE responsible to the grain industry for a number of aspects of Australia’s pesticide residue management framework including:
- Arranges with industry the collection of appropriate samples for chemical residue testing.
- Analyses a range of grains and processed products for various chemical residues.
- Conducts that residue testing on both domestic and exported grain and processed products.
- Publishes results of those programs to support the grain industry and verify that good agricultural practice has been used in chemical management (i.e., chemical residues are below the applicable MRL).
- Where an export destination is specified, assesses residue testing results against applicable overseas MRLs and provides reports and advice to the relevant exporter.
- Liaises with the States and Territories for traceback investigation where non-compliance is detected.
- Consults with industry on changes required to the testing program based on changing chemical availability, regulations and market concerns.
- Is the focal point of contact with the Chair NWPGP regarding industry feedback to Government on changing market chemical regulations and other relevant matters.
As required in the Australian grain industry “Code of practice for the management of grain along the supply chain”, participation in the NRS program is mandatory for all GTA members involved in:
- Out-turning grain on the domestic market to an end-processor (who is not defined as a primary producer)
- All bulk grain exporters
- All container exporters
- Where relevant, operators of facilities who provide grain as part of the above services.
For more information on the above and details of other NRS activities, see
Laboratories conducting residue testing for the grains program
See Technical Guideline Document No. 20 National Residue Survey Participation for further information on the NRS program and industry requirements for participation in the NRS.
For a brief overview on information contained in the links above, click here
Codex Committee on Pesticide Residues
The Codex Committee on Pesticide Residues (CCPR) is a Committee operating under the auspices of the Food and Agriculture Organization of the United Nations and World Health Organization (FAO/WHO) Food Standards Programme – the Codex Alimentarius Commission (CAC). There are over 180 countries that are members of Codex, including a number of international observers. Australia is an active member of Codex.
Sometimes authorized uses of the pesticides on food crops result in residues. Codex Alimentarius sets MRLs for pesticides on specific foodstuffs or food groups traded internationally to protect the health of consumers in accordance with the recommendations of the Joint FAO/WHO Meeting on Pesticide Residues (JMPR). However some countries establish their own MRLs as a result of the evaluations carried out by national or regional agencies on risk assessment.
Codex MRLs (CXLs) are adopted based on the recommendations of the JMPR evaluations and in accordance with Good Agricultural Practices (GAP) data. Therefore food resulting from products that comply with the MRLs will be toxicologically acceptable. The JMPR is a technical body that produces risk assessments that are not only the basis for CCPR risk-management decisions but also widely used by governments, industry and researchers worldwide when developing their own legislation.
The CCPR:
- Meets annually to review JMPR recommendations for MRLs by commodity and chemicals. Once agreed, CCPR makes those MRL recommendations to CAC for adoption. Once adopted by CAC, the MRLs are published on-line in the MRL database.
- Is currently hosted by China and first met in 1966.
- Prepare Priority Lists of pesticides for evaluation by JMPR.
- Establishes MRLs for pesticides in food and feed moving in the international trade.
- Establishes MRLs based on an 8 step procedure but also has an accelerated procedure for more rapid development of MRLs, without compromising the objectives of food safety.
- Regularly review older MRLs and may recommend revocation of those MRLs.
- Reviews sampling and methods of analysis for the development of MRLs.
- May also consider other issues of relevance to food safety and trade in relation to pesticide residues.
Countries may apply Codex MRLs in a number of ways:
- Fully defer (e.g., adopt) to Codex MRLs for all commodities and chemicals.
- Partly adopt Codex MRLs (e.g., only some Codex MRLs).
- Utilise Codex procedures for MRL development within their own regulations.
- Adopt Codex Crop Groupings, residue definitions in their own legislation.
- A combination of any/none of the above.
- Countries may not utilise Codex MRLs or procedures but participate at Codex.
For more information on CCPR and the JMPR refer to:
Schedule of CCPR meetings and papers, including past and forthcoming meeting
For a brief overview on information contained in the links above, click here
Overseas Regulators
Each country has its own regulations, and government department(s) responsible for managing chemical regulations and MRLs in particular. There are a range of complexities in relation to MRLs set by overseas governments, similar to that as noted in relation to adoption of Codex MRLs.
Further details of regulations applying in each country are listed under the MRL section
Pre-shipment fumigation
In addition to MRLs that apply, a number of export markets may also require pre-shipment fumigation of export cargoes of grain. Cargoes may also need to be fumigated in-transit. These requirements vary by country and may include aspects such as:
- Specifying particular fumigants to be used e.g., methyl bromide, phosphine.
- Specifying various label directions such as rates to be used depending on the temperature.
- May require specific permits to be generated and approved by APVMA if those label directions are not generally approved in Australia.
- Generally require government certification that the treatment has been conducted according to requirements.
- Be general without specific details of fumigants or treatments.
Where pre-shipment fumigation is required by an importing country, any MRLs applying to those commodities and chemicals in each market must still be met by industry.
All details of those pre-shipment fumigation requirements are listed by market and commodity as outlined in the Department of Agriculture, Fisheries and Forestry MICoR database.
