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Chapter 2 - Regulating and managing food risks

Strategic imperative

To maintain a transparent and evidence-based approach to regulating and managing food risks.

Highlights 2013–14

  • Led the Australian delegation to four committees of the Codex Alimentarius Commission and participated in working groups.
  • Participated in the activities of two international food safety liaison groups (chemical and microbial) and chaired the meetings of the microbial group.
  • Continued to chair two major international behavioural and regulatory analysis groups of food regulators from the United States of America, Canada, United Kingdom, New Zealand and Australia. Regulators from South Korea and Ireland joined the regulatory economics group during the year.
  • Finalised a Cost of Illness Model that calculates the costs to the community of outbreaks of foodborne pathogens.
  • On behalf of Australia, continued to chair (with China) the APEC Food Safety Cooperation Forum of food safety regulators, involving 21 member economies.
  • Released the results of the analysis of the 24th Australian Total Diet Study. The first phase of the report included an analysis of acrylamide, aluminium and perchlorates.
  • Coordinated one incident under the National Food Incident Response Protocol, involving New Zealand whey protein concentrate suspected of being contaminated with Clostridium botulinum.
  • Coordinated 66 food recalls, mainly due to undeclared allergens and microbial contamination.


While developing food standards is one of FSANZ's main responsibilities, we also protect public health and safety by maintaining an evidence base of the risks associated with food and by coordinating systems that monitor and remove unsafe foods from sale in Australia.

We carry out these responsibilities in partnership with government agencies in Australia and New Zealand, within the parameters and policies issued by the Forum on Food Regulation. Our work plan, therefore, reflects our statutory obligations and topical issues identified by the ministers that make up the Forum.

In developing the FSANZ business plan for 2014–15, the Executive has identified projects of highest priority for implementation in the next year because they are already substantially completed, or have been requested by ministers or deemed to address an important public health and safety issue. Other projects of importance will be rolled out in the forward years.

These projects comprise reviews undertaken by the agency, usually but not exclusively through proposal processes. A summary of these projects appears in Table 8, with the relevant strategic imperative from the FSANZ Corporate Plan. Further details appear against these projects elsewhere in this report.

Table 8: High priority projects for 2014–15

FSANZ work area Projects Strategic imperative (2013–15 Corporate Plan)

Food labelling

  • Labelling Review projects
  • Health claims transition
  • Allergen labelling exemptions

Support informed consumer decisions about food by collecting and providing relevant information

Public health

  • Lupins as an allergen

Regulatory burden reduction

  • Code revision
  • Organisational reform

Build and sustain food standards and practices to support high standards of public health protection and a dynamic and sustainable food manufacturing sector

Chemical food safety

  • Tutin
  • Cyanogenic glycosides
  • Nutritive substances and novel foods
  • Sulphites and benzoates

Microbiological food safety

  • Raw milk products
  • Review of microbiological limits
  • BSE country assessments

Food incidents and recalls

  • Incident response
  • Food recalls

Maintain a transparent and evidence-based approach to regulation and the management of food risks

Strategic science

  • Science Strategy
  • Data management

Evidence-based development

  • Nutrient chemical projects
  • GM technologies review
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FSANZ's regulatory approach

To ensure a safe food supply and well-informed consumers in Australia and New Zealand, regulation may be required. FSANZ has been changing its processes and enhancing our capacity for analysing regulatory and non-regulatory interventions, particularly in how we apply the disciplines of economics and other social sciences.

Several years ago, FSANZ decided to enhance its social science capacity to obtain a better understanding of the behaviour of individuals and groups to ensure risk management options are informed by behavioural evidence. More recently, we have focussed our attention on developing our economic capacity to enhance our assessment of the effects of various management options.

Our initiatives in these areas mirror a more general interest across the public sector to ensure regulation is both effective in dealing with issues and efficient in delivering a net benefit to society as a whole. This government-wide desire to improve and minimise regulation is reflected in the role of the Office of Best Practice Regulation and the whole-of-government agenda to reduce the regulatory burden on industry.

During 2013–14, FSANZ finished consolidating its regulatory and behavioural capacity into a single section. This has resulted in greater integration of the economic and behavioural elements of our assessments of problems and enhanced capacity to develop and assess options to address these problems.

A key output of the renewed focus on regulatory practice has been the development of tools that improve our efficiency and enhance the transparency of our work. For example, in 2013–14, we finalised a Cost of Illness Model that calculates the costs to the community of outbreaks of foodborne pathogens. The model includes costing for the four most common pathogens: salmonella, campylobacter, E. coli and listeria. We expect the model to reduce the resources required for future costings of foodborne diseases. It can be extended to other pathogens when data become available.

Development of this model is an example of productive collaboration across the disciplines in FSANZ, drawing on both risk managers and risk assessors. The model was formally peer reviewed by an academic health economist and informally reviewed by a range of economists in similar regulatory agencies in the United States, Canada and the United Kingdom.

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Strengthening our evidence base

Internal knowledge

Dietary exposure assessments

Dietary exposure assessments provide an estimate of the magnitude of exposure for the population to a nutrient or food chemical.

In 2013–14, we provided dietary exposure assessment input for food standards applications (e.g. vitamin D in breakfast cereals) and proposals (e.g. maximum residue limits for imported food commodities) and for other purposes, including surveillance activities (arsenic in apple and pear juice) and completed work relating to a survey for cyanogenic glycosides in plant-based foods.

FSANZ provided input to assessments for packaging chemicals for the National Industrial Chemicals Notification and Assessment Scheme, and to the Department of Health review of nutrient reference values for fluoride and sodium. We also evaluated dietary exposure assessments conducted by the Australian Pesticides and Veterinary Medicines Authority (APVMA) when assessing the safety of residues in food for new or amended uses of agricultural and veterinary chemicals, including assessments for chemicals under review by the APVMA.

During the year, we also provided input and expertise for dietary exposure assessments to the 78th meeting of the FAO/WHO JECFA meeting on Veterinary Drugs that considered several veterinary drugs and their residues in food.

Burden of foodborne illness in Australia

The project to re-estimate the burden of foodborne illness in Australia is now complete. Conducted by the Australian National University's National Centre for Epidemiology and Public Health with funding provided by FSANZ, the New South Wales Food Authority and the Australian Government Department of Health, the study uses contemporary foodborne disease data and advanced modelling approaches to estimate the number of cases of illness and common long-term conditions acquired in Australia from contaminated food, as well as the number of hospitalisations and deaths.

Due for publication later in 2014, the full report will be hosted on the Health website along with a summary article in Food Standards News. Articles will also be published in the open access peer-reviewed scientific journal Emerging Infectious Diseases.

Estimates of foodborne illness are an important evidence base for the development of food safety policy and legislation.

Pyrrolizidine alkaloids

Pyrrolizidine alkaloids (PA) are naturally occurring toxins that appear in a number of Australian and New Zealand plants. Dietary exposure arising from the current PAs levels in honey needs evaluation for safety. We have been providing technical leadership and coordination in generating new toxicological data that will help us characterise (understand the nature of) the risk to public health and safety of PAs.

We completed work to characterise the relative toxicity of sentinel PAs. Once these new data have been generated, we will undertake a risk assessment and consider whether any further measures are necessary to protect health. These data will also be submitted to the Joint FAO/WHO Expert Meeting on Food Additives (JECFA) so they are considered in international risk analysis.

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External expertise

FSANZ Fellows

The FSANZ Fellows Program creates a network of experts in a range of disciplines to provide advice and contribute to the work of FSANZ. Throughout the year, six of our Fellows were re-appointed by the FSANZ Board for a further three-year term, as they are making valuable contributions to ongoing work and will continue to contribute to the future work of the agency.

The current membership of the FSANZ Fellows program is listed in Table 9.

Table 9: FSANZ Fellows 2013–14

FSANZ Fellow Background or expertise Affiliated institution
Appointment period October 2011–14

Professor David Fraser

Vitamin D

University of Sydney

Associate Professor Winsome Parnell

Surveys and infant nutrition

University of Otago

Associate Professor Peter Williams


University of Canberra

Appointment period May 2012–15

Professor Ken Buckle

Food science, processing and microbiology

University of New South Wales

Professor Nigel French

Molecular epidemiology and risk research

Massey University

Professor Stephen Goodall

Health economist

University of Technology

Professor Seppo Salminen

Intestinal micro biota and health, probiotics and prebiotics, health claims

University of Turku

Appointment period June 2013–16

Assistant Professor Jason Riis

Experimental psychology and behavioural economics

Harvard Business School

Appointment period December 2013–16

Dr Laurence Eyres

Food technology


Dr Heather Greenfield

Food composition

University of New South Wales

Professor Peter Langridge


University of Adelaide

Professor Brian Priestly

Health risk assessment

Monash University

Professor Murray Skeaff


University of Otago

Professor Mark Tamplin

Microbiology and food safety

University of Tasmania

Engagement with academic institutions

The FSANZ student project program provides links with Australian academic institutions. This program provides an opportunity for students to undertake projects of relevance to FSANZ and food regulation. In 2013–14, students from the University of New South Wales, the University of Wollongong, the University of South Australia and the University of Canberra completed projects contributing to the work priorities of FSANZ in food regulation and food safety.

Regulatory Science Network

FSANZ is currently the vice-chair of the Regulatory Science Network (RSN), a network of Australian Government agencies responsible for regulating chemicals (including radio-isotopes) and biological agents. The aim of the RSN is to forge closer links and promote common approaches to regulatory science between the agencies.

The RSN achieves its goals by improving operational effectiveness, undertaking capacity building exercises, promoting consistent approaches to regulatory decision making and developing proposals for consideration by the Regulators' Forum.

During the year, the RSN developed a presentation titled Finding Common Ground —establishment of a regulatory science network at the 7th Annual Conference of the Society of Risk Analysis—Australia New Zealand in Sydney; co-hosted an Endocrine Disrupting Chemicals workshop in Canberra; and developed and convened a Science Communication Symposium for regulatory agencies, also in Canberra.

OzFoodNet Working Group

OzFoodNet—Australia's enhanced foodborne disease surveillance system—was established in 2000 to improve national surveillance and conduct applied research into the causes of foodborne illness. FSANZ is a member of the OzFoodNet Working Group and participates in discussions on current epidemiological investigations of foodborne illness.

The information reported by OzFoodNet on the nature and extent of foodborne illness outbreaks is an extremely important component of FSANZ's evidence base and is used extensively in our standards development, risk assessment, incident response and communication activities.

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International networks

Codex Alimentarius Commission

The Codex Alimentarius Commission is the international food standards setting body established by the United Nations Food and Agriculture Organization and World Health Organization. Codex develops international food standards, guidelines and codes of practice for an international food code that contributes to the safety, quality and fairness of food trade.

The FSANZ Act requires FSANZ to have regard to the international harmonisation of food standards and to use the best available scientific evidence in regulatory decision making. During the year, we participated in and led the Australian Delegation at a number of meetings of Codex committees, as summarised in Table 10:

Table 10: FSANZ participation in the work of the Codex Alimentarius Commission, 2013–14

Codex committee FSANZ participation

36th Session of the Codex Alimentarius Commission; and 68th Session of the Executive Committee of the Codex Alimentarius Commission

FSANZ participated at this meeting as a scientific advisor for the Australian delegation. At this meeting, FSANZ provided input into the development of international food standards, with the opportunity to promote harmonisation with international standards.

35th Session of the Codex Committee on Nutrition and Foods for Special Dietary Uses

FSANZ led the Australian delegation to this meeting, and agreed to convene an electronic working group for revised or additional Nutrient Reference Values-Requirements for the general population for seven vitamins and minerals.

35th Session of the Codex Committee on Food Hygiene

FSANZ led the Australian delegation to this meeting. The focus this year was to progress the Draft Code of Hygienic Practice for Low-Moisture Foods and the corresponding review of microbiological criteria for Salmonella.

46th Session of the Codex Committee on Food Additives

FSANZ led the Australian delegation to this meeting, and led the work on the alignment of food additive provisions in Codex commodity standards with the General Standard for Food Additives (GFSA). FSANZ chaired the in-session working group that covered both the alignment work and the endorsement of food additive provisions forwarded by the Codex Committee on Fish and Fishery Products.

8th Session of the Codex Committee on Contaminants in Food

FSANZ led the Australian delegation to the working groups on the Maximum Levels (MLs) for lead, methylmercury in fish and radionuclides in a variety of foods, and aflaxtoxins in cereals.

World Health Organization Collaborating Centre for Food Contamination Monitoring

FSANZ is a World Health Organization (WHO) Collaborating Centre for food contamination monitoring, and carries out several activities to support WHO programs. During the year, we submitted data from the 19th, 20th, 21st, 22nd and 23rd Australian Total Diet Studies (ATDS) to the WHO in the GEMS/Food format to assist the work of WHO expert working groups.

In collaboration with the Western Pacific Regional Office of the WHO (WPRO), FSANZ was invited as a temporary advisor to a meeting titled Strengthening INFOSAN (International Food Safety Authorities Network) and National Food Control Systems in Asia. This meeting provided the opportunity to facilitate the participation of Asian economies in INFOSAN and strengthen national food control systems within Asia.

Food and Agricultural Organization of the United Nations

A senior FSANZ staff member spent most of 2013 at the FAO, providing scientific advice for chemical and microbiological food safety.

International food safety liaison groups

The International Food Chemical Safety Liaison Group (IFCSLG) and International Microbial Food Safety Liaison Group (IMFSLG) provide a forum for regulators from different countries to discuss current and emerging issues relating to risk analysis and food surveillance. FSANZ is an active participant in this forum.

During the year, the IFCSLG considered surveys of caffeine in a range of food products and beverages, arsenic in juices and rice, hydrocyanic acid in apricot kernels, radionuclide testing and testing for aluminium, perchlorate and dicyandiamide in some foods. It also compared knowledge and experiences with food safety issues associated with bisphenol A, 3-MCPD esters and glycidyl esters, food irradiation and acrylamide and discussed the development of a global teaching module for food chemical risk assessment.

As chair of IMFSLG since January 2013, FSANZ has actively engaged with international food regulators to collaborate and share issues of mutual interest related to the microbial safety of food. As well as discussing topics such as establishing microbiological criteria for Listeria monocytogenes in ready-to-eat foods and safety and labelling of mechanically tenderised meat, the group also considered the setting of performance targets for reducing specific pathogens.

International behavioural and regulatory analysis groups

FSANZ continued to draw on key domestic and international expertise in applying the economic and behavioural sciences to our regulatory practice.

The Social Sciences and Economics Advisory Group, comprising New Zealand and Australian academics acted as the primary source of review and challenge to the academic rigour of our work.

The International Social Sciences Liaison Group and the Food Safety Regulatory Economics Working Group—both chaired by FSANZ—provided input from, and exchange among, agency-based economists and social scientists from international risk agencies. Both these groups include regulators from the United States of America, Canada, United Kingdom, New Zealand and Australia. In 2013–14, membership of the Food Safety Regulatory Economics Working Group was expanded to include regulators from South Korea and Ireland.

Relationships in the Asia-Pacific region

The APEC Food Safety Cooperation Forum (FSCF) is a forum of food safety regulators, involving 21 member economies working together to strengthen food safety systems and promote harmonisation of member country's food standards with international standards. The APEC FSCF is co-chaired by FSANZ (on behalf of Australia) and the People's Republic of China (General Administration of Quality Supervision, Inspection and Quarantine).

In 2013, APEC Trade Ministers recognised the continued efforts of the APEC FSCF and its Partnership Training Institute Network in developing food safety capacity in the region and contributing to the alignment of domestic regulations with international standards. Ministers supported the progress to advance regulatory cooperation and convergence, where FSANZ is leading a project on the harmonisation of pesticide maximum residue limits.

During the year, FSANZ (on behalf of Australia) has made significant progress in developing the framework for the newly formed APEC Food Safety Incident Network (FSIN) and associated procedures for the secretariat function and member participation. The FSIN will operate through a portal on the INFOSAN website, commencing in 2014–15.

FSANZ will collaborate with the Chilean General Directorate of International Economic Affairs, Ministry of Foreign Affairs to finalise secretariat arrangements for FSIN for 2015.

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Monitoring food hazards


Implementation Subcommittee for Food Regulation Coordinated Food Survey Plan

FSANZ oversees the surveillance and monitoring activities of the Implementation Subcommittee for Food Regulation (ISFR). In 2014, three activities conducted as part of the ISFR Coordinated Food Survey Plan were completed:

  • national surveillance program for genetically modified foods, led by New South Wales Food Authority
  • cyanogenic glycosides in plant-based foods, jointly led by New Zealand Ministry for Primary Industries and FSANZ
  • research on pharmaceuticals in weight loss products, led by FSANZ.

Food Surveillance Network

FSANZ chairs the Food Surveillance Network (FSN), a group that continues to be an important forum for food regulatory agencies in Australia and New Zealand to discuss, plan and implement food surveillance activities. The FSN supports the work of ISFR, particularly with respect to its three-year Coordinated Food Survey Plan and implementation of its surveillance and monitoring activities.


Australian Total Diet Study

The Australian Total Diet Study (ATDS) provides a comprehensive assessment of Australian consumers' dietary exposure (intake) to pesticide residues, contaminants and other substances. It enables FSANZ to monitor the food supply to ensure that existing food regulatory measures provide adequate protection of consumer health and safety.

We are releasing the results of the analysis of the 24th ATDS in two parts. The first phase of the report, which included the analysis of acrylamide, aluminium and perchlorates, was published on the FSANZ website in April 2014. The second phase of the report will focus on food packaging chemicals, including bisphenol A (BPA), epoxidised soy bean oil (ESBO), phthalates, perfluorinated compounds, and printing inks. We expect to publish the report in early 2015.

We have also conducted the autumn and summer food sampling period for the 25th ATDS, with a focus on the concentrations of metal contaminants, agricultural and veterinary chemicals and radionuclides in Australian foods and beverages.

Case study: consultations with industry on the outcomes of the 24th ATDS

The results of the 24th ATDS showed that there was a slight exceedance above the relevant health guidance value for aluminium in children aged 2 to 5 years, who are high consumers of particular foods. While this was not considered to be a major public health and safety issue, FSANZ believes it is undesirable for there to be exceedances in the long term.

Acrylamide levels were also surveyed in the study. The levels found for acrylamide were generally lower than, or comparable to, those reported in international studies. However, given concerns about the human health effects of acrylamide, levels should be kept as low as reasonably achievable.

FSANZ continues to consult with industry bodies on the levels of acrylamide and aluminium found. For aluminium, FSANZ is speaking with industry representatives to determine whether current permissions for aluminium-containing food additives in the Code are still appropriate for the established technological need; or if they could be decreased to lower dietary exposures, particularly for young children.

FSANZ continues to encourage industry to explore ways e.g. new processing techniques, to reduce the levels of acrylamide.

Trans fatty acid survey

This survey aimed to determine the current levels of trans fatty acids (TFAs) in a range of processed and take-away foods available in Australia and New Zealand. The survey follows previous surveys on TFAs, the most recent being an ISFR-coordinated survey managed by the New South Wales Food Authority in 2008–09.

We have completed sampling and analysis for this study and are expecting to publish the report in late 2014.

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Food incidents

The protection of public health and safety is FSANZ's primary objective. Through their Food Acts, states and territories ensure that food businesses do not sell unsafe food. Together, FSANZ and the jurisdictions implement risk management systems that have resulted in Australia having one of the safest food supplies in the world.

Food incident response capability

In 2013–14, FSANZ strengthened its capacity for responding to food incidents by working with state and territory food authorities, other Australian Government agencies, and international partners to develop a framework for monitoring and coordinating response activities to emerging food safety issues and food safety incidents.

During the year, the National Food Incident Response Protocol (NFIRP) was triggered once due to possible contamination of batches of New Zealand whey protein concentrate with Clostridium botulinum. The protocol was triggered to facilitate collaboration and the exchange of information between Australia and New Zealand. FSANZ coordinated the response to support government agencies responsible for ensuring that no suspect product had reached local markets.

In March 2014, ISFR endorsed the formation of a Bi-national Food Safety Network to facilitate the coordination, information sharing and communication on food safety matters between Australia and New Zealand. The network extends current arrangements under the NFIRP to situations where bi-national discussion of food-related issues would be beneficial.

Internationally, FSANZ has led the establishment of the APEC FSIN, an initiative that will allow for early identification and communication of imported food issues and incidents resulting from products sourced, manufactured or originating from APEC economies. Managing food safety incidents and alerts is a shared responsibility and the strength of this framework is in the links, to key personnel, made possible through a formalised, sustainable communication network.

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Food recalls

In the event that an unsafe food finds its way into the marketplace, the Australian jurisdictions, FSANZ and food businesses collaborate to withdraw that food from sale or, if already sold, to ask consumers to return the product to the place of purchase.

Mandatory reporting

Under the Competition and Consumer Act 2010, suppliers are required to report to the ACCC consumer product-related incidents, including food-related incidents, where a death or serious injury or illness has resulted requiring medical or surgical treatment by, or under the supervision of, a qualified doctor or nurse.

The ACCC refers food-related mandatory reports directly to the relevant state or territory food enforcement agency (where consent from the supplier has been received), for possible action. FSANZ simultaneously receives copies of these mandatory reports for national monitoring and reporting purposes. Since mandatory reporting commenced in 2011, we have received 1,122 food-related mandatory reports from the ACCC. This figure represents approximately 40% of all mandatory reports (food and non-food) received by the ACCC, up to and including 30 June 2014.

Most mandatory reports are received from businesses in the food manufacturing and retail sectors, followed by the catering sector. Food-related mandatory reports are mainly associated with alleged food poisoning.

Food authorities follow up on mandatory reports referred to them from the ACCC. In most cases, the reports have been adequately investigated by the company without intervention by an enforcement agency. A very small number of cases resulted in the enforcement agency determining that the company needed to take further action.

Food recalls


We coordinated 66 food recalls during the year (Figure 1). The recalls were mainly due to undeclared allergens (Figure 2) and microbial contamination, predominantly Listeria monocytogenes and E. coli (Figure 3).

Figure 1: Food recalls coordinated by FSANZ in 2013–14, by recall category

Figure 2: Reason for undeclared allergen recalls

Figure 3: Reason for recalls due to microbial contamination

Industry guidance

In May 2014, FSANZ published the 7th edition of the Food Recall Industry Protocol. The revised protocol was developed by FSANZ in collaboration with the state and territory food enforcement agencies and key industry stakeholders, and will help food businesses be well-prepared to undertake food recalls.

The protocol provides information on recalling food in Australia and guidance for food businesses on writing a food recall plan. The new edition includes information about traceability, which helps businesses understand the importance of tracking food one step forward and one step backwards at any point in the supply chain and the different ways of communicating recalls to the public, including the use of social media. The protocol is available on the FSANZ website (in PDF and HTML) at

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