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Chapter 1 – Develop food regulatory measures (standards) or contribute to other control measures using the risk analysis process

  • Introduction
  • Summary of food regulatory activity
  • Standards development
  • Public health and safety
  • Improving our risk management outcomes


FSANZ uses risk analysis to develop food regulatory measures (standards or codes of practice). FSANZ also apply risk analysis to other work, for example, when we respond to requests for advice from other agencies in the food regulation system including the assessment of risks for imported foods.

Risk analysis is an internationally recognised process used to assess risks to human health from food-related hazards. It has three parts — risk management, risk assessment and risk communication.

In recent years, FSANZ has taken action to ensure our risk management decisions continue to be based on the best available evidence and are supported by a high level of consultation and transparency. Our risk management decisions are based on an awareness of contemporary public health issues, emerging technologies used in the wider food industry, and current and emerging community concerns.

FSANZ will reinforce and build on the work that has been done to strengthen our risk analysis capacity and leverage this work through collaborative partnerships with international counterparts.

FSANZ will also explore the options available to undertake a greater role in promoting the use of scientific evidence and good practice in a deregulatory and globalised environment. Surveillance and monitoring will be important elements of our approach to ensuring that regulation is outcome-focussed. Enhanced traceability systems and the proactive collection and analysis of market intelligence will increase our capacity to respond to new or emerging risks. Keeping local data is also important in the making, application and evaluation of internationally recognised standards.

Our activities and work plans are identified in our supporting business plans, the Science Strategy, and Communication and Stakeholder Engagement Strategy.

Summary of food regulatory activity

Applications and proposals gazetted

Detailed information on applications and proposals processed in 2015–2016 is contained in Appendix 2. Information on FSANZ's process for assessing applications and proposals can be found on the FSANZ website in the FSANZ Application Handbook at

FSANZ has an open and transparent assessment process and therefore has a pro-disclosure approach to the publication of material on the web related to applications and proposals. This means that all applications to change the Australia New Zealand Food Standards Code (dependent on copyright), as well as submissions on applications and proposals, are published on our website free of charge. FSANZ does not provide any material that is confidential commercial information or where the Agency has been asked to keep certain information confidential, such as personal information.

The executive summary from an application is published when FSANZ publicly notifies its decision to accept the application on completion of the administrative assessment. When the call for submissions occurs, the main application is placed on the website. However, if a request for access is made from the public prior to release, it will be provided. Supporting information such as raw studies or references may be available to the public on request. Submissions are published on the website as soon as possible after the end of the public comment period.

FSANZ Application Handbook

FSANZ can make guidelines which set out mandatory information and format requirements that applications must include. If these requirements are not met, then FSANZ has the power under section 26 of the FSANZ Act to reject an application after it has initially been lodged. These guidelines are a legislative instrument for the purposes of the Legislation Act 2003, but are not subject to sun setting or disallowance.

FSANZ has compiled these mandatory requirements within Part 3 of the FSANZ Application Handbook (Handbook). Parts 1 and 2 of the Handbook are for information only. Part 1 provides an overview of the food standards system. Part 2 provides general information to assist on application procedures. It includes information on fees, assessment and food standard-setting processes.

An ongoing internal working group manages amendments to the Handbook under the oversight of the Standards Management Officer. Amendments to the Handbook, including taking account of the revision to Chapters 1 and 2 of the Food Standards Code, took effect on 1 March 2016.

Notification Circulars

FSANZ Notification Circulars include notices that are required to be given to the public, submitters and appropriate government agencies under the FSANZ Act. Stakeholders, including applicants, submitters or those who have indicated an interest in a particular application or proposals mentioned in a circular, are advised of its publication. Circulars may also mention other matters of interest to FSANZ's stakeholders including cost recovery information or decisions relating to BSE country categories.

In addition, FSANZ maintains a subscription list of over 5300 stakeholders who have registered to receive alerts when a circular is published. Circulars are published on the FSANZ website. Any applicant, submitter or those who have indicated an interest in a particular application or proposal mentioned in a circular without an email address are sent hard copies of the specific circular.

Table 1: Notification Circulars published
2012–13 2013–14 2014–15 2015–16
24 27 28 36

Standards Development Work Plan

FSANZ is required to develop and publish a three-year plan for applications and proposals on which it intends to develop standards or variations to standards, no later than 30 June each year. In developing the plan, FSANZ must consult interested persons and review and update the plan at least every three months.

The FSANZ Executive formally reviews the Work Plan every month. New unpaid applications and proposals do not appear on the Work Plan until the Executive considers their priority and approves timeframes and resources for the assessments to proceed. However, the Work Plan is not a static document, and the Standards Management Officer, who has responsibility for managing the Work Plan, updates it much more frequently — often on a daily basis. The version found on FSANZ's website is updated each time a Notification Circular is published.

FSANZ called for submissions on the Work Plan on 18 May 2016 with a closing date of 17 June 2016. One submission was received and the comments were considered by FSANZ.

Table 2 shows the number of applications received and proposals prepared as at 30 June 2016 (received from 1 October 2007). Table 3 shows the number of remaining applications, proposals and potential proposals on the Work Plan (received or prepared prior to 1 October 2007) as at 30 June 2016.

Applications received, or proposals prepared before 1 October 2007, continue to be assessed under the procedures in place at that time. The tables below therefore reflect the two types of assessment approaches.

While the number of applications received and proposals prepared by FSANZ was similar to last year, our workload continues to be characterised by increased demands and complexities.

Table 2: Applications and proposals on the Work Plan (received or prepared from 1 October 2007 onwards)*
As at 30 June 2013 30 June 2014 30 June 2015 30 June 2016
General procedure 11
(3 paid)
(2 paid)
(7 paid)
(1 paid)
Minor procedure 0 0 0 0
Major procedure 7 4 3 3
High level health claims 0 0 0 0
Urgent applications or proposals 0 0 0 0
Under review 1 1 0 1
TOTAL 19 19 22 4
With the Ministerial Forum or awaiting notification to the Ministerial Forum 2 2 8 5
Estimated waiting time for unpaid applications 2 months approx. 6 months approx. 9 months approx. 7 months approx.

* Table 2 does not include potential applications and proposals for which an administrative assessment has commenced, but not yet completed, as these have not yet been placed on the Work Plan, or where an application has been accepted and proposal prepared, but was not on the Work Plan as at 30 June.

Assessment procedures

General procedure This procedure applies to all applications or proposals, unless they are being considered under the minor, major or high level health claim variation procedures or are considered 'urgent' under Division 4 of the FSANZ Act.
Minor procedure This procedure applies to applications or proposals for the variation of a food regulatory measure that, if made, would not directly or indirectly impose, vary or remove an obligation on any person; or create, vary or remove a right of any person; or otherwise alter the legal effect of the measure.
Major procedure This procedure applies to applications or proposals that involve such scientific or technical complexity that it is necessary to adopt this procedure in considering them; or involves such a significant change to the scope of the food regulatory measure that it is necessary to adopt this procedure in considering them.
High level health claims variation procedure This procedure is used for applications or proposals to make a change to the list of high level health claims (HLHCs) as permitted in Standard 1.2.7. Once an application has been accepted or proposal prepared, the HLHC expert committee and Food Regulation Standing Committee are formally notified and comments on the application or proposal are sought. For applications, public submissions are not called for unless an applicant has asked FSANZ for this to occur.
Urgent applications or proposals These applications and proposals are considered urgent under Division 4 of the FSANZ Act. Under these provisions, FSANZ is required to assess the variation to the Food Standards Code within 12 months of the date of effect of the gazetted variation. FSANZ may then either re-affirm its original decision or prepare a proposal for a further variation or replacement variation.
Table 3: Applications and proposals on the Work Plan (received or prepared before 1 October 2007)
As at 30 June 2013 30 June 2014 30 June 2015 30 June 2016
Group 1 5 4 2 1
Group 2 4 4 4 4
Under review 0 0 0 0
TOTAL 9 8 6 5
With the Ministerial Forum or awaiting notification to the Ministerial Forum 0 0 0 0
Estimated waiting time Group 2 Unknown Unknown Unknown Unknown

Group 1 is for applications or proposals raising health and safety issues being progressed as a priority or identified by jurisdictions as warranting priority.

Group 2 is for unpaid applications or proposals scheduled for commencement in order of receipt.

FSANZ's capacity to manage cost-recovered applications (as indicated in Table 1) also impacts on the Agency's ability to manage its workload as it is difficult to forecast the number and complexity of cost-recovered applications likely to be received.

Tables 4 and 5 summarise FSANZ's performance in developing food standards.

Table 4: Total applications received and accepted onto the Work Plan and proposals prepared
2012–13 2013–14 2014–15 2015–16
Applications 6 42 181 181
Proposals 7 63 6 5
TOTAL 13 10 24 23
  1. This includes any applications received in this year and accepted onto the Work Plan in the following year. This figure therefore may be adjusted in the next annual report.
  2. This includes one cost-recovered application which was rejected because the applicant chose not to pay the fees owing for an exclusive capturable commercial benefit by the due date.
  3. This includes one proposal which was prepared and then abandoned within this financial year.
Table 5: Applications and proposals finalised
2012–13 2013–14 2014–15 2015–16
Approvals made by the FSANZ Board 18 11 18 23
Final assessments made by the FSANZ Board 0 0 1 0
Applications withdrawn or rejected*

Proposals abandoned
2 5 2 1
TOTAL completed 20 16 21 24

* This includes potential applications rejected following an administrative assessment.

Further information on the above can be obtained from Appendix 2. There also may be some discrepancies between Tables 5 and 8 where decisions have been made in one financial year and the notification of that decision made in the next financial year.

Table 6 provides information about any significant variation from the timetable established in the Work Plan for the consideration of applications and proposals during 2015–16.

Table 6: Reasons for significant delays in consideration of applications and proposals in 2015–16
Application/ Proposal Step Variation1 Reason
A1095 — Natamycin — Extension of Use in Yoghurt Assessment, preparation of draft food regulatory measure and call for submissions 1 year
1 month
Completion of assessment delayed due to other work priorities, the complexity of issues and the need for external peer review of the risk assessment.

Withdrawn by applicant on 24 March 2016 before assessment completed.
A1102 — L-carnitine in Food Assessment, preparation of draft food regulatory measure and call for submissions 1 year Delay due to other work priorities and the complexity and scope of the application.
A576 — Labelling of Alcoholic Beverages with a Pregnancy Health Advisory Label Draft assessment 7 years
5 months + (from date Final Assessment due)
Work has been deferred until mid-2016 at the request of the applicant.
P1016 — Hydrocyanic Acid in Apricot Kernels and Other Foods Approval
Dec 2012
2 years
9 months
Following on from earlier delays, approval delayed to allow ministers to consider at a face-to-face meeting.
P1024 —
Revision of the Regulation of Nutritive Substances and Novel Food
Assessment 2 years
8 months
Delay due to the complexity of issues. There are also resourcing issues.
P1026 —
Lupin as an Allergen
Assessment, preparation of draft food regulatory measure and call for submissions 2 years
11 months
Completion of assessment delayed due to other work priorities and collection of cost benefit data. Also, preparation of a Regulatory Impact Statement to comply with the Office of Best Practice Regulations (OBPR) requirements.
P1027 — Managing Low-level Ag and Vet Chemicals without Maximum Residue Limits Assessment, preparation of draft food regulatory measure and call for submissions 2 years
11 months
Completion of assessment delayed due to other work priorities and requirement for further consultation with key stakeholders. Further delay due to refinement of the dietary modelling and drafting.
P1028 —
Infant Formula Products
Call for submissions on consultation paper 2 years
1 month
Delay due to complexity of issues.
Assessment 11 months Delay due to complexity of issues and delayed release of consultation paper.

Note: Scope of project has been limited to infant formula due to resourcing issues. Timelines have therefore been changed and consultation opportunities reduced.
P1030 — Health Claims — Formulated Supplementary Sports Foods and Electrolyte Drinks Approval 1 year
9 months
Delay due to complexity of issues raised in submissions and other work priorities.
P1031 — Allergen Labelling Exemptions Assessment, preparation of draft food regulatory measure and call for submissions 1 year
1 month
Assessment delayed awaiting further technical information. Targeted consultation resulted in a decision to delay release whilst further information was sourced.
Approval 1 year
4 months
P290 — Food Safety Programs for Catering Operations to the General Public Final assessment 11 years
1 month + (from date final assessment due)
Delayed pending further implementation strategy work required by jurisdictions.
P298 — Benzoate and Sulphite Permissions in Food Draft assessment 10 years 11 months + (from date final assessment due) Delayed due to the need to collect and evaluate further data. Also, draft assessment delayed while revised Regulatory Impact Statement prepared and considered by the OBPR.

Abandoned June 2016.

1 Variation based on indicative timeframes in the administrative assessment report against timeframe indicated in FSANZ Work Plan as at 30 June.

Table 7 shows the status of the applications and proposals received or prepared prior to 1 October 2007 and which remain on the Work Plan.

Table 7: Status of remaining applications and proposals received or prepared prior to 1 October 2007
Application / Proposal Step Reason
A530 — Permission for English Farmhouse Cheddar made from Raw Milk Initial assessment Received 12 February 2004 — waiting on advice from the applicant following completion of work on raw milk products (P1022).
A531 — Use of Raw Milk in Cheese Production Initial assessment Received 16 February 2004 — waiting on advice from the applicant following completion of work on raw milk products (P1022).
A576 — Labelling of Alcoholic Beverages with a Pregnancy Health Advisory Label Draft assessment Received 17 February 2006 — see Table 6.
A613 — Definitions for Nutritive Substance and Nutritive Ingredient Initial assessment Received 11 August 2007 — awaiting advice from the Applicant and consideration of P1024.
P290 — Food Safety Programs for Catering Operations to the General Public Final assessment Prepared 13 May 2004 — see Table 6.

Reviews requested by members of the Australia and New Zealand Ministerial Forum on Food Regulation (Ministerial Forum)

A request for the review of a FSANZ decision to amend the Food Standards Code may be sought by a majority of members of the Ministerial Forum, that is six out of 10, following a notification of the FSANZ Board's decision on a draft standard or variation to a standard. More details on the review process are in the Application Handbook.

Table 8: Notification outcomes
2012–13 2013–14 2014–15* 2015–16
Approval decisions notified 17 12 18 23
Final assessment decisions notified 0 0 1 0
Requests for review 1 (6%) 0 (0%) 1 (5.5%) 1 (4.3%)
Review decisions notified 2 0 1 0

* The figures in this column may differ from those provided in the previous year's annual report as review requests may be received by FSANZ after the deadline for publication.

Under the 2008 Inter-Governmental Food Regulation Agreement, ministers can only request reviews of FSANZ decisions based on one or more of the following criteria:

  1. it is not consistent with existing policy guidelines set by the Ministerial Council1
  2. it is not consistent with the objectives of the legislation which establishes FSANZ
  3. it does not protect public health and safety
  4. it does not promote consistency between domestic and international food standards where these are at variance
  5. it does not provide adequate information to enable informed choice
  6. it is difficult to enforce or comply with in both practical or resource terms
  7. it places an unreasonable cost burden on industry or consumers.
  8. One request for a review was received in 2015–16 in relation to Application A1090 — Voluntary Addition of Vitamin D to Breakfast Cereal. The grounds for the review were that the decision was not consistent with existing policy guidelines set by the Ministerial Forum.

Ministerial policy guidelines and statements

The Ministerial Forum is responsible for the development of food regulatory policy for domestic and imported foods and the development of policy guidelines for setting food standards for domestic and imported foods. In developing or reviewing food regulatory measures and variations to food regulatory measures, under section 18 of the FSANZ Act, FSANZ must have regard to any written policy guidelines formulated by ministers and notified to FSANZ for these purposes.

In 2015–16, no guidelines were notified.

On 2 December 2015, ministers provided FSANZ with a statement clarifying the original intent of the Policy Guideline for the Fortification of Food with Vitamins and Minerals.

Additional work requested by the Ministerial Forum

On 2 December 2015, FSANZ was requested to commence work on the revocation of the country-of origin labelling standard in the Food Standards Code ahead of the commencement of a mandatory information standard on country of origin labelling under Australian Consumer Law.

On 18 April 2016, FSANZ was requested to begin work on developing a draft variation to the Food Standards Code to permit low-THC hemp seeds as food. Advice on the restriction of marketing and advertising, as well as information relating to the need to set a cannabidiol limit, was provided to FSANZ to be taken into consideration during the assessment of the proposal.

Gazettal of variations

In 2015–16, variations to standards arising from 13 applications were gazetted (compared to five in 2014–15). Variations to Standards arising from 10 proposals were gazetted (compared to seven in 2014–15). The increase from last year is explained by the larger number of applications received in the previous financial year that were finalised, along with several proposals which had taken several years to complete. See Appendix 2 for more detail.

Table 9: Gazettal of variations to the Food Standards Code
2012–13 2013–14 2014–15* 2015–16
Arising from applications 12 9 5 13
Arising from proposals 6 2 7 10
TOTAL 18 11 12 23

Maximum Residue Limits (MRLs)

The Australian Pesticides and Veterinary Medicines Authority (APVMA) has the power to amend Schedule 1 of Standard 1.4.2 for MRLs (see Appendix 2 for further information). From 1 March 2016, the relevant MRL standard is Schedule 20.

FSANZ is required by the FSANZ Act to provide advice about applications and variations that are being considered by the APVMA that may result in an amendment to

the Food Standards Code. FSANZ retains responsibility for making amendments in relation to specific import MRLs, as well as the Standard itself and the other schedules to the Standard.

FSANZ notifies the public via its Notification Circular (including links to relevant web pages) of progress with any proposed amendments at key stages during the APVMA's MRL consideration process.


1 Now known as the Australia and New Zealand Ministerial Forum on Food Regulation

Standards development

Addition of substances to certain foods and use of new technologies

Food additives, processing aids and irradiated fruit and vegetables

Regulatory milestone 2015–16 Number of applications gazetted: 7

The following applications were gazetted:

  • A1098 — Serine Protease (Chymotrypsin) as a Processing Aid (Enzyme)
  • A1099 — Serine Protease (Trypsin) as a Processing Aid (Enzyme)
  • A1103 — Citric and Lactic Acids as Food Additives in Beer and Related Products
  • A1107 — Asparaginase from Bacillus subtillis as a Processing Aid (Enzyme)
  • A1108 — Rebaudioside M as a Steviol Glycoside Intense Sweetener
  • A1110 — Food derived from Insect-protected Soybean Line MON87751A1111 — Bacteriophage S16 & F01a as a Processing Aid

Sulphites and benzoates in food

Regulatory milestone 2015–16 Abandonment

In 2013, the Office of Best Practice Regulation (OBPR) requested further work on the regulatory impact statement for permissions for benzoates and sulphites in food to clarify the risk associated with exceeding the Acceptable Daily Intake (ADI) for sulphites.

Since then, FSANZ has strengthened the evidence of the potential cost of adverse health effects in the population exceeding the ADI, commissioned a study on the possible cost of illness due to the health effects of excessive sulphite use, and consulted further with stakeholders on the proposed option and the impacts this may have on business.

Genetically modified (GM) foods

Regulatory milestone 2015–16 Number of GM foods approved and gazetted: 1

The following GM applications were gazetted:

  • A1097 — Food derived from Herbicide-tolerant & Insect-protected Corn Line MON87411
  • A1106 — Food derived from Herbicide-tolerant and Insect-protected Corn Line 4114
  • A1110 — Food derived from Insect-protected Soybean Line MON87751
  • A1112 — Food derived from herbicide-tolerant corn line MZHG0JG
  • A1114 — Food derived from High Yield Corn Line MON87403

Nutritive substances and novel food

Regulatory milestone 2015–16 Release of first call for submissions

FSANZ released the first call for submissions in December 2015 and conducted workshops with stakeholders around the time of the release. The first call for submissions highlighted the current issues associated with the operation of the nutritive substance and novel food provisions in the Food Standards Code. FSANZ considered that in order to improve the regulation of nutritive substances and novel foods, an alternative approach should be developed. FSANZ presented a framework for a graduated approach to managing the varying levels of risk associated with new foods. The graduated approach was developed as an example of how an alternative approach, proportionate with risk, could operate. The approach included consideration of industry self-assessment for certain foods coupled with the existing FSANZ pre-market approval route to market. This was for foods with uncertain risk considered to require a greater level of assessment and regulatory oversight.

FSANZ received detailed commentary and suggestions for alternative elements of a graduated approach during the workshops and in submissions. Based on this feedback, FSANZ will develop options for the second call for submissions, which is planned in the second quarter of 2017. Further targeted stakeholder consultation will occur before the second call for submissions is released.

The provision for exclusive use of approved novel foods is also being reviewed.

Low THC hemp seeds as food

Regulatory milestone 2015–16 FSANZ to complete proposal in 2016–17

Hemp foods are prohibited in the Food Standards Code. In January 2015, ministers rejected FSANZ's draft variation to amend the Food Standards Code to permit foods derived from the seeds of low-THC hemp. Ministers highlighted concerns regarding law enforcement issues, marketing and labelling, and cannabinoids other than THC that may be present in hemp foods. Ministers requested that these issues be investigated by the Food Regulation Standing Committee (FRSC). Several FRSC working groups were established, and a series of research reports addressing these issues were completed and presented to ministers in March 2016.

At the March 2016 meeting, the Ministerial Forum agreed to request that FSANZ prepare a proposal to permit the sale of food containing low-THC hemp, taking into account the results of these research projects. In particular, FSANZ was asked to consider whether limits for cannabinoids other than THC may be necessary for hemp foods (including cannabinoid acid precursors), government policy relating to marketing and labelling of hemp foods, and international approaches to maximum levels of cannabinoids in hemp foods.

FSANZ called for submissions in mid-2016 and expects to complete the proposal in late 2016 for consideration by the Ministerial Forum.

Voluntary addition of vitamin D to breakfast cereal

Regulatory milestone 2015–16 Review in progress following notification of the Ministerial Forum's clarification statement on the policy guideline Fortification of Food with Vitamins and Minerals

In response to the Ministerial Forum's request, FSANZ commenced a review of its decision to permit the addition of vitamin D to breakfast cereal to a maximum claim amount of 2.5 micrograms per normal serve. The Ministerial Forum also notified FSANZ of its clarification of the Policy Guideline Fortification of Food with Vitamins and Minerals in December 2015.

Voluntary addition of vitamins and minerals

Regulatory milestone 2015–16 Permission approved by the FSANZ Board in December 2015

FSANZ assessed and approved an application to permit the addition of vitamins and minerals to nut-based, seed-based, or nut- and seed-based beverages equivalent to the levels permitted for other dairy analogues of cows' milk. The label advisory statement applicable to certain other dairy analogues cautioning young children's consumption was also extended to these beverages.


Country-of-origin labelling

Regulatory milestone 2015–16 Proposal approved by the FSANZ Board in June 2016

FSANZ approved an amendment to the Food Standards Code to remove country-of-origin labelling requirements. This was in response to new arrangements introduced by the Australian Government, with requirements now under Australian Consumer Law. FSANZ called for submissions in January 2016 and received 15 submissions.

Sodium claims (food containing alcohol) and vitamin and mineral claims

Regulatory milestone 2015–16 Amendments to the Food Standards Code gazetted in December 2015

FSANZ addressed an inconsistency in the conditions for vitamin and mineral claims between Standards 1.2.7 and 1.3.2. FSANZ also approved an amendment to permit nutrition content claims about salt and sodium in relation to foods (excluding beverages) containing more than 1.15 per cent alcohol by volume.

Nutrition content and health claims (amendments to existing Food Standards Code provisions)

Regulatory milestone 2015–16 Amendments to the Food Standards Code gazetted in December 2015

FSANZ approved amendments to the Food Standards Code to address inconsistencies and lack of clarity associated with Standard 1.2.7 and related standards, to ensure that Standard 1.2.7 operates as intended. This included approval of an exemption for certain elements of the Health Star Rating system from the requirements for claims in the Food Standards Code.

Allergen labelling exemptions

Regulatory milestone 2015–16 Finalisation

An allergen labelling exemptions proposal was gazetted in order to remove the requirement for mandatory declaration of allergens in respect of fully refined soy oils, tocopherols and phytosterols derived from soy; glucose syrup derived from wheat starch; and distilled alcohol from dairy or wheat components. Completion of this work brings considerable benefits for industry by way of reduced labelling requirements and greater harmonisation with international trade; and for allergic consumers being offered wider food choices.

Public health

Infant formula

Regulatory milestone 2015–16 Call for submissions (consultation paper) in February 2016

FSANZ reviewed the Food Standards Code requirements for infant formula (birth to <12 months) and publicly consulted on its preliminary views on composition, safety and labelling of infant formula. Infant nutrition, consumer understanding, manufacturing and trade developments, the international regulatory context and the Ministerial Forum's Policy Guideline Regulation of Infant Formula Products were considered in forming our view. The public consultation period was extended to 14 weeks to allow more time for stakeholder input. FSANZ also held workshops during the consultation period to guide stakeholders through the complex paper.

Lupin as an allergen

Regulatory milestone 2015–16 Public consultation on a draft variation to the Food Standards Code

During 2015–16, FSANZ continued work on the analysis of the cost and benefits associated with the management of the risk of allergy arising from food containing lupin. This work included extensive interaction with the OBPR. The time taken for FSANZ and OBPR to reach consensus on the content of the cost-benefit report delayed the public consultation on the risk management options. A FSANZ report on the outcomes of the cost-benefit analysis, including the risk management options considered and a draft variation to require mandatory declaration of lupin in food is planned for release for public comment in mid-2016. The FSANZ Board will consider submissions as part of its final consideration of the Proposal in late 2016, which will include a final risk management option.

Food safety

Cyanogenic glycosides in food

Regulatory milestone 2015–16 Amendments to the Food Standards Code gazetted in December 2015

FSANZ completed work on a proposal to manage the acute dietary risk from consumption of raw apricot kernels.

In October 2015, the FSANZ Board approved draft variations to prohibit the retail sale of raw apricot kernels to consumers and to require kernels that are to be added to food as an ingredient to be rendered safe through processing or treatment. This measure was considered warranted given the evidence which identified a risk to public health and safety. It was also considered the most effective in addressing that risk.

Pyrrolizidine alkaloids (PAs)

Regulatory milestone 2015–16 Completion of toxicological study and submission to Joint FAO/WHO Expert Meeting on Food Additives (JECFA)

PAs are naturally occurring toxins that appear in a number of Australian and New Zealand plants.

FSANZ has successfully coordinated a toxicological study in partnership with the Australian Government's Rural Development Research and Development Corporation, and New Zealand's Ministry for Primary Industries and Bee Products Standards Council. The study aimed to characterise the risk to public health and safety of PAs found at low levels in honey.

The study was completed and FSANZ submitted the data to JECFA for its evaluation. These new data appear reassuring with regard to the safety of a sentinel PA found in Australian and New Zealand honeys. Nevertheless, FSANZ will consider whether any further measures are necessary to protect public health and safety, and whether any further research should be undertaken.

Contaminants in oils

Regulatory milestone 2015–16 Effective ongoing monitoring of research activities in relation to 3-MCPD esters and GEs

3-monochloro-1, 2-propanediol (3-MCPD) esters and glycidyl esters (GEs) occur in some foods as a result of the refining process for oils and fats. The toxicology of these substances is uncertain and is the subject of a global research effort.

FSANZ has liaised with the Australian Oilseeds Federation to raise awareness of this issue within the industry and has kept a watching brief on any new information by the International Food Chemical Liaison Group. To facilitate further characterisation of the risk of 3-MCPD esters for Australian and New Zealand consumers, the New Zealand Ministry for Primary Industries (NZ MPI) will undertake a survey on levels of 3-MCPD esters in infant formula, oils and in a range of other foods such as margarines.

The next steps are to confirm the scope of the survey, identify foods which might contain MCPD esters and establish a methodology. NZ MPI hopes to have the survey completed in 2016.

Bovine spongiform encephalopathy (BSE)

Regulatory milestone 2015–16 BSE risk status assigned to two countries, the status of other countries reconfirmed

Australia's revised BSE policy requires FSANZ to undertake a rigorous food safety assessment to determine the BSE food safety status of applicant countries intending to import beef and beef products to Australia. The FSANZ BSE food safety assessment is comprised of a desk assessment of information provided by the applicant country and an in-country inspection that verifies compliance with BSE-related controls throughout the beef production chain within the applicant country.

Countries which are assigned a Category 1 or Category 2 status by FSANZ are eligible to import beef or beef products to Australia. Certification requirements are implemented by the Department of Agriculture and Water Resources.

During 2015–16, FSANZ conducted an in-country verification inspection to Sweden as part of the assessment of BSE food safety risk of Sweden and completed the assessment for Sweden with Category 1 BSE risk status. FSANZ also completed the assessment for Japan with a Category 1 BSE risk status. FSANZ received an application from Canada in September 2015 which was subsequently withdrawn.

FSANZ also received annual BSE update information from 12 countries: Argentina, Brazil, Chile, Croatia, Japan, Latvia, Lithuania, Mexico, the Netherlands, New Zealand, the United States, and Vanuatu. This information was assessed and the previously assigned BSE food safety risk status for each of the countries was confirmed, except for Croatia which was upgraded from Category 2 to Category 1 based on revised surveillance data.

Maximum residue limits (MRL's)

Regulatory milestone 2015–16 One proposal completed

In 2015–16, FSANZ looked at one MRL harmonisation proposals to help promote overseas trade. One has been completed and MRLs for 48 chemicals and 220 chemical-food commodity combinations are now included in the Food Standards Code through Amendment 163. Requests for 117 chemicals for about 220 chemical-food commodity combinations have been received from domestic and overseas interested parties for the second proposal. Action on this proposal is anticipated to be completed by May 2017, if there is no request for a review.

Work has progressed on low-level inadvertent chemical residues in food commodities. A robust risk assessment process was developed in consultation with the Australian Pesticides and Veterinary Medicines Authority (APVMA) and used to propose an MRL for all other foods except animal food commodities MRL for 19 chemicals currently listed in the Food Standards Code. Gazettal is anticipated by December 2016 if no review is requested.

FSANZ maintains close liaison with APVMA and the Department of Agriculture and Water Resources with regard to its MRL activities. The exchange of information is important in addressing domestic and international trade issues relating to agricultural and veterinary pesticides residues in food commodities presented for sale on the Australian market.

Improving our standards development outcomes

Reform of the Australia New Zealand Food Standards Code (Food Standards Code)

Regulatory milestone 2015–16 Revised Food Standards Code took effect March 2016

FSANZ revised the Food Standards Code, following a review of legal issues, particularly the failure of the former version to provide adequate linkages to offence provisions in the Food Acts. The revised Food Standards Code took effect on 1 March 2016.

FSANZ will consult with jurisdictions and industry on a number of complex issues which were outside the scope of the original revision proposal. These include modernising the technical language, a review of the processing aids standard, traceability through-chain to expedite incident management, application of labelling requirements, and a review of the additives Standard and related schedules.

Regulatory impact statements

To ensure a safe food supply and well-informed consumers in Australia and New Zealand, a level of regulation may be required. FSANZ aims to ensure that any regulation is effective and efficient, in line with the Australian Government's agenda to reduce red tape.

In recent years, FSANZ has enhanced our social science capabilities to understand better the behaviour of individuals and groups, allowing us to deliver risk management options informed by behavioural evidence. During 2015–16, FSANZ focussed its attention on developing its economic capacities, to enhance our assessment of the impacts of various management options.

A key output of the renewed focus on regulatory practice has been the development of costing tools that increase the efficiency of how we do our work, while also enhancing the transparency of our work. These include the Cost of Illness model, Labelling Costing model, and recently we commenced work on a Government Cost model.



Last section Annual performance statements

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