Our Regulatory Measures
Applications and Proposals gazetted from 1 July 2004 - 30 June 2005
Managing public health issues arising from food
Monitoring and evaluating hazards in food
Strengthening the evidence-base for food standards decision making
Objectives
- Development and evaluation of the Food Standards Code and other regulatory measures (Portfolio Budget Statement 2004-2005).
- Effective management and enhancement of the standards development process (Portfolio Budget Statement 2004-2005).
- Establishment and implementation of a common regulatory approach and evaluation strategies with other agencies (Portfolio Budget Statement 2004-2005).
- Work with our government partners to develop food standards through the bi-national food regulatory arrangements (FSANZ Corporate Plan 2003-2006).
- Use of good regulatory practice in the delivery of food regulatory outcomes (Portfolio Budget Statement 2004-2005).
Highlights
- 24 Applications finalised.
- 5 Proposals finalised.
- 100% of regulatory impact statements met the requirements of the Office of Regulation Review.
- Successfully managed number of significant public health issues arising from food.
- Completion of the seafood standard.
Performance
The performance indicators for Our Regulatory Measures:
- the number of standards Applications finalised within statutory timeframes;
- the number of regulatory impact statements satisfying the Office of Regulation Review’s requirements; and
- our management of food emergencies and public health issues arising from food.
Overview
Last year we reported that the increasing demands and complexities of a rapidly changing food environment are placing further pressures on our capacity to fully meet stakeholder expectations. We are a demand-driven agency and, in the discharge of our statutory functions, we face acute resource challenges and competing priorities.
We have little control over the number and complexity of Applications we receive and we are being seriously stretched by several significant and complex projects.
An assessment of the FSANZ Work Plan over recent years has revealed significant and increasing workload pressures on the agency. Statistics show a growing backlog of Applications and Proposals listed on that plan, along with an increasing waiting period for unpaid Applications. While there has been a marginal decrease in the number of recent Applications, the pressures on our capacity to deliver remain.
In the past we have given priority to the implementation of policy guidelines and to the expectations of the Australia New Zealand Food Regulation Ministerial Council. We also need to consider requests from the Ministerial Council for reviews of work already completed. At the same time, we must accept and process all Applications received.
Complex projects such as health claims, fortification and the development of the primary production standard for seafood have made a significant call on our resources. We estimate, for example, that work on the seafood standard and on health claims alone (out of a total of 67 listed on the FSANZ workplan) have engaged about 20% of staff involved in food standards development work.
In order to meet expectations on matters such as fortification, FSANZ has delayed a number of other important regulatory projects including sports foods and food type dietary supplements.
The standards development process administered by FSANZ is only one component of the food regulatory system. This system includes policy development, standards development and implementation. These components are mutually dependent, and ultimately the timeliness and quality of food standards is determined by how well the entire system functions.
The number of Applications received and Proposals commenced during 2004-2005 declined compared with the previous year (see Table 1). Never-the-less, a number of factors continue to contribute to our inability to process work in a manner that meets stakeholder expectations.
During the year we have dealt with a number of issues of significant public interest. Some are ongoing and include:
- proposals dealing with seafood, poultry meat, dairy, and country of origin labelling;
- responses to requests for work in areas such as vitamin and mineral fortification, health claims and novel foods;
- food emergencies and public health issues arising from food-related issues including red food dyes, the safety of acrylamide, and norovirus contamination of imported oysters;
- emerging issues including food from cloned animals, polybrominated diphenyl ethers, and trans fatty acids;
- non-standards work, including management of food recalls; and
- data collection activities, including the Australian Total Diet Study, analysis of food compositions, and evaluations of the impact of key standards.
FSANZ has already taken a number of steps to address industry and jurisdictional concerns about the timeliness of the FSANZ process. We have made further changes to the structure and format of our assessment reports to ensure that key issues and recommendations are more readily identifiable. We have strengthened our consultation processes including the use of public briefings and more targeted engagement, particularly for contentious issues.
FRSC Review
During the year the Food Regulation Standing Committee (FRSC) initiated a review of our assessment and approval processes and our treatment of confidential commercial information. The purpose of the review is to examine legislative and other impediments that prevent our processes from being more effective.
We provided input to the review.
The review identified the main strengths of our processes as our clear focus on the protection of public health and safety based on the best available scientific evidence; the transparency of those processes; and the public scrutiny of our decision-making processes through open consultation. The main weakness of the system, however, is the timeframe for decision-making and the legislative process for developing or amending a standard.
While the number of Applications and Proposals made to or by FSANZ respectively, decreased compared to last year, our workload continues to be characterised by increased demands and complexities. Table 1 shows the number of Applications received and Proposals commenced since July 2002 in all Work Plan Groups.
Our capacity to manage cost recovered Applications (Group 3) also impacts on our ability to manage our workloads as it is difficult to forecast the number and complexity of cost recovered Applications we are likely to receive.
Applications and Proposals were completed during the standard-by-standard review of the Code undertaken since 1994 but were held over to be finalised (adopted) as a package by the Ministerial Council in November 2000. Accordingly the 2000-2001 period saw the greatest number of Applications and Proposals finalised.
Ministerial Council Reviews
Since 2002, the number of reviews requested by the Ministerial Council has increased from 3 (9% of matters notified to the Ministerial Council) to 8 (25%) for the year ending June 2005. In May, the Ministerial Council requested, for the first time, a second review on a matter (fortification of foods with calcium).
Matters referred to FSANZ by the Ministerial Council ranged from genetically modified foods, processing aids, phytosterols, fortification, to minor omnibus amendments.
In all cases FSANZ reaffirmed its approval.
A recent Ministerial Council decision for review requests to be accompanied by more specific and detailed reasoning may assist in clarifying the matters for further consideration by FSANZ and assist in reducing the turn around time.
Applications and Proposals gazetted from 1 July 2004 – 30 June 2005
Based on Applications received, 24 variations or amendments to standards in the Code were gazetted (compared with 20 last year). On the basis of Proposals raised by FSANZ, a further five variations or amendments to standards in the Code were gazetted (compared with ten last year).
Detailed information on Applications and Proposals finalised and processed in 2004 – 2005, are contained in Appendix 1, 2 and 3.
Policy guidelines and work requested by Ministers
The Australian Government, States and Territories and the New Zealand Government are represented by their health ministers on the Ministerial Council and/or by ministers from other relevant portfolios such as agriculture, industry or trade, to ensure a whole-of-government approach to food regulation.
The Ministerial Council is responsible for the development of domestic food regulatory policy and the development of policy guidelines for setting domestic food standards. It has the capacity to adopt, amend or reject standards and to request that these be reviewed.
Policy guidelines resulting from decisions made by the Ministerial Council are subsequently referred to FSANZ.
Ministerial policy guidelines
Review of the Intent of Part 2.9 of the Food Standards Code – Special Purpose Foods
At its meeting in March, the Ministerial Council agreed that FSANZ should conduct a review of the intent of Part 2.9 of the Food Standards Code - standards for special purpose foods.
The purpose of the review is to ensure that Part 2.9 of the Code is only used for those foods that are prepared for at-risk groups whose dietary requirements cannot always be satisfied by a normal diet. It should not apply to foods that are promoted and consumed as general foods.
This work will be undertaken through current Proposals already underway namely, the Review of Sports Foods and Food for Special Medical Purposes. We expect work to be completed in late 2006.
Nutrition, Health and Related Claims(notified to FSANZ on 18 December 2003)
Nutrition, health, and related claims are those that indicate the presence or absence of a nutrient, or describe or indicate a relationship between the consumption of food and a health outcome. FSANZ has been considering the regulation of these claims for some time.
In December 2003 the Ministerial Council endorsed a nutrition, health and related claims policy guideline. The policy aims to ensure that the health and safety of the public is protected, while still facilitating innovation by the food industry and trade.
We are progressing a Proposal related to the use of nutrition, health and related claims. We consider that the appropriate use of nutrition, health and related claims has a significant role in promoting improved health through increased and informed dietary choice and provides an incentive for the research and development of food products which offer the consumer health benefits. The project is very complex, drawing a diverse range of views both within and across stakeholder groups (i.e. consumers, public health professionals, industry and the jurisdictions). The Initial Assessment Report, published in August 2004, attracted a large number of detailed submissions. Publication of the Draft Assessment Report is expected late in 2005.
Part of the health claims proposal includes assessment for possible pre-approval of several diet-disease relationships in which diet may reduce the risk of a serious disease. We have selected seven diet disease relationships that had been approved overseas. Experts reviewed the evidence base for these relationships, including commenting on six previously conducted reviews by Health Canada. A Scientific Advisory Group has peer reviewed the first three expert reviews and advised FSANZ on their rigour, quality and conclusions. The remaining reviews will be considered in 2005-2006.
In order to take an evidence based approach to the formulation of the new regulatory arrangements, we have commissioned a number of research projects and surveys relating to consumer use and perception of health claims, the present use of health and related claims on food products, a cost-benefit analysis and a review of the scientific evidence supporting the use of claims which relate to the reduction in risk of serious disease. We have worked closely with the Standards Development Advisory Group for health claims throughout the project. We have also met with key individuals involved in the evaluation and regulation of health claims from other jurisdictions (eg Health Canada, US Food and Drug Administration and UK Joint Health Claims Initiative) to gain insight into experiences with the implementation of health claim frameworks.
Country of Origin Labelling of Food (notified to FSANZ on 18 December 2003)
In December 2003 the Ministerial Council agreed to a policy guideline for mandatory country of origin labelling of food.
FSANZ is working on a Proposal to develop a new standard, having regard to the policy guideline. The Food Standards Code currently has an Australia-only transitional standard requiring country of origin information for packaged foods and certain unpackaged foods. A New Zealand-only requirement relates to wines. The new Proposal aims to reinforce country of origin information necessary to make informed food choices.
A draft report released in March 2005 generated considerable interest from a wide range of stakeholders. Submissions received, followed by targeted consultations, identified a number of substantive issues. A further round of consultation was undertaken in August / September 2005. A final report will go to the FSANZ Board in late September and the Ministerial Council will have an opportunity to consider the report in late October.
Food Safety Management in Australia (notified to FSANZ on 18 December 2003)
In December 2003 the Ministerial Council agreed that specific high-risk sectors of the food industry be required to implement mandatory food safety programs. The policy guidelines developed by the Ministerial Council guide the standards development process.
The high-risk sectors included in mandatory food safety programs include:
- food service, whereby potentially hazardous food is served to vulnerable populations;
- harvesting, processing and distributing raw oysters and other bivalves;
- catering operations serving food to the general public; and
- businesses producing manufactured and fermented meat.
The implementation of food safety programs for oysters and other bivalves has been addressed in the Primary Production and Processing Standard for Seafood.
The requirement for food safety programs improves the safety of the Australian food supply by ensuring all potential food safety hazards are identified and controlled in high-risk sectors. The aim is to safeguard consumers from foodborne illness without creating undue impost on industry or consumers.
We have prepared a number of Proposals that include the development of standards to cover Food Service to Vulnerable Populations, Catering Operations to the General Public, and Producers of Manufactured and Fermented Meat.
During the year, we progressed work with the States and Territories, industry and consumers to implement the policy guidelines. Discussions have been held with relevant State and Territory agencies to enable application and enforcement of food safety plans for retail of manufactured meats. There is broad support for the mandating of Standard 3.2.1 for all producers of manufactured and fermented meats. The Proposal has progressed through the Draft Assessment stage.
With respect to Food Safety Programs for Food Service to Vulnerable Populations the main issues concerned the frequency of audits required, the duplication of requirements with existing accreditation systems, the scope of the definition, and exemptions for family day care. This Proposal has also progressed through the Draft Assessment stage.
We have sought clarification from the Ministerial Council on the nature of businesses or business activities that are intended to be captured by Ministerial policy guidelines.
Review of Novel Food (notified to FSANZ on 18 December 2003)
Novel foods are those non-traditional foods for where there is insufficient knowledge in the broad community to enable safe use. A Standard requiring pre-market approval of novel foods has been incorporated into the Code since June 2001 (Standard 1.5.1.) but the food industry has expressed concern about the subjective nature of the current definition, the scope of the definition and the protection of commercially sensitive information.
We received policy guidance on novel foods from the Ministerial Council in December 2003. Ministers asked FSANZ to review the standard and associated user guide and to consider issues raised by stakeholders. The current definition in the standard is open to subjective interpretation and the scope of the novel foods definition needs to be refined with particular attention given to the identification of the appropriate triggers of a pre-market assessment of novel foods.
The policy guidelines recommend that, in reviewing the standard, FSANZ gives consideration to the higher order principles and to the specific principles as well as to the issues raised by stakeholders during the FRSC consultation.
The aim of the revised standard is to provide greater clarity about our process to determine if a food is novel.
Fortification of Food with Vitamins and Minerals (notified to FSANZ on 28 May 2004)
The Ministerial Council agreed to a policy guideline for the Fortification of Foods with Vitamins and Minerals in May 2004. The policy covers both mandatory and voluntary fortification of food.
Ministers agreed that vitamins and minerals may be added to food where there is, for example, demonstrated evidence of inadequate dietary intake or potential health benefit, and the fortification of a food will not result in harm.
As part of the strategy for the management of fortification work, we have developed theFortification Implementation Framework(the Framework) as a practical guide for implementing the policy guideline in the context of the standards development process. The document details, in the light of the policy guideline, our revised approach to regulatory decision-making on both the mandatory and voluntary addition of vitamins and minerals to food.
The Ministerial Council advised that two significant public health issues, the occurrence of neural tube defects and mild iodine deficiency, warranted high priority consideration of mandatory fortification with folic acid and iodine respectively.
We achieved considerable progress on both projects during the year. We prepared a Proposal for the consideration of mandatory fortification with folic acid and resumed work on a Proposal to consider mandatory addition of iodine to food.
We released Initial Assessment Reports for both Proposals for public consultation and prepared two major reports on the health risks and benefits of increased intake of folic acid and of iodine. We have sought clarification on policy advice from the Ministerial Council whether mandatory fortification is likely to be the most effective strategy in each case and on the management of health monitoring and review in the event that mandatory fortification proceeds.
In support of its fortification work, we have also established a Fortification Standards Development Advisory Committee to advise on fortification matters. The Committee members are drawn from industry, consumer groups, public health professionals and government.
Primary Production Work
The development of national ‘paddock-to-plate’ standards is the responsibility of FSANZ and aims to:
- ensure that food safety is addressed across the entire food chain;
- provide nationally consistent standards that will set a benchmark for industry obligations to produce safe food;
- provide minimum imposts on industry to achieve the most effective food safety outcomes;
- harmonise with international standards; and
- increase public confidence in the safety of food products.
In developing the primary production and processing standards, FSANZ works within the framework of the Australia and New Zealand Food Regulation Ministerial Council Overarching Policy Guideline on Primary Production and Processing Standards and FSANZ’s Protocol for the Development of Primary Production and Processing Standards.These guidelines emphasise the food safety nature of these standards.
In addition to statutory consultation, further consultative activities have been built into the development process for the Primary Production and Processing Standards. This reflects recognition of the need for close consultation with industry, regulators and consumers throughout the development of the standards, since the level of awareness of FSANZ processes within the primary production sector may be minimal.
Further details of our consultative mechanisms and stakeholder engagement may be found in the section on Our Stakeholders.
Other workrequested
Review of Minimum Age Labelling of Foods for Infants
In April 2003, the Ministerial Council requested that FSANZ review the minimum age labelling requirements for infant foods to resolve an apparent inconsistency with the revised Australian National Health and Medical Research Council (NHMRC) Dietary Guidelines for Children and Adolescents released in June 2003. In addition Ministers asked that a review of minimum age labelling also consider and accommodate New Zealand infant feeding guidelines.
The inconsistency relates to the age of introduction of solids as the current Standard permits infant foods to be labelled as suitable ‘from four months’. The revised NH&MRC infant feeding guidelines recommend the introduction of solids at around six months, whereas the New Zealand Food and Nutrition Guidelines for Healthy Infants and Toddlers (aged 0-2 years)recommend that solids be introduced to infants aged between four to six months.
In order to avoid uncertainty and possible confusion for consumers and health care providers it is proposed to amend the Standard by varying the minimum age reference to ‘around 6 months’.
Work on this Proposal has been delayed due to the undertaking of consumer research in relation to infant foods labelling and the priority given to fortification related work.
We anticipate that work on this Proposal will be finalised in 2005-2006.
Maximum Residue Limits Harmonisation (within Australia)
Currently, residues of agricultural and veterinary chemicals are prohibited in food unless they comply with specific limits stipulated in the Code. Maximum Residue Limits (MRLs) are set to ensure that residues of these substances are kept as low as possible consistent with the domestic use of chemical products to control pests and diseases in plants and animals. It also ensures that only those residues that have been assessed as ‘safe’ by regulatory authorities in Australia are permitted in food. The Australian Pesticides and Veterinary Medicines Authority (APVMA) is responsible for approving agricultural and veterinary chemicals for agricultural use in Australia while FSANZ is responsible for validating the dietary exposure assessment and consulting with the public before adopting the MRL in the Food Standards Code.
Of concern is the lengthy processes for the approval of an agricultural and veterinary chemical, firstly by APVMA for agricultural use and then by FSANZ to ensure that a food for sale is safe for human consumption.
In August 2003, the Ministerial Council agreed to a process to harmonise the MRL setting procedures of the APVMA and FSANZ to establish one set of published MRLs that regulates safe food and safe chemical use in agriculture. The agreed approach is based on harmonisation of administrative processes, monitoring and review of the new harmonised assessment process and, subject to satisfaction with the new processes, the issuing of a single MRL.
An Interdepartmental Advisory Committee comprising officials from the APVMA and FSANZ and the Department of Agriculture, Fisheries and Forestry (DAFF) and the Department of Health and Ageing (DoHA) met in May to progress the harmonisation of MRLs and it is intended to take a paper to the August meeting of the Food Regulation Standing Committee (FRSC).
Regulatory approaches to managing low-level residues of agricultural and veterinary chemicals in the food supply.
FSANZ has been considering alternative regulatory approaches that could apply to low-level residues of agricultural and veterinary chemicals in food where there are no public health and safety issues. This issue has arisen out of recent detections of substances in food such as nitrofurans and 2,4-D residues in globally traded food. At present, advances in the sensitivity of analytical techniques for detecting low levels of chemicals is tending to drive regulation, leading to disruptions to international trade – this is an inappropriate situation.
We have proposed some modifications to the approach used to regulate residues of agricultural and veterinary chemicals and have sought policy advice from the Food Regulation Standing Committee (FRSC) on these issues during 2005. FRSC has established a working group to progress the matter.
Addition of caffeine to foods
In April 2003 the Ministerial Council agreed, until further evidence became available, to maintain the current additive permission for caffeine and to restrict the use of new products containing non-traditional caffeine rich ingredients (including guarana) to boost the caffeine content in other food.
The Ministerial Council requested further investigation on the use of guarana and guarana extract, and on the definition of cola drinks.
We undertook a dietary exposure assessment to determine caffeine exposure from the diet by vulnerable Australian population sub-groups. We concluded that the estimated exposures to caffeine for vulnerable groups (children 2-19 years) has changed very little between 1995 and 2003. Although energy drinks were more available in 2003, and more were consumed than in 1995 resulting in higher intakes of caffeine for consumers, the population of people selecting these type of drinks remains small.
We plan to publish a technical paper on the findings of this research.
Ministerial request for review
As reported earlier in this report, there was a marked increase during the year in the number of reviews requested by the Ministerial Council. The Council asked FSANZ for a review of its decisions on eight occasions this year.
During 2003-2004 we were asked to review our decision to permit the voluntary addition of calcium to fruit and vegetable juices, fruit and vegetable drinks, soups and cracker-type biscuits. We completed a First Review in relation to this Application and re-affirmed our approval of the approved draft standard.
In May, the Ministerial Council requested a Second Review - the first time the Council has requested a Second Review on a matter.
The Ministerial Council also requested a First Review of our decision:
- concerning the definition of wholegrain in Standard 2.1.1;
- to approve the use of phytosterol esters derived from vegetable oils as a novel food ingredient in breakfast cereals;
- to approve the use of phytosterol esters derived from vegetable oils as a novel food ingredient in low-fat milk and low-fat yoghurt;
- to approve the use of tall oil phytosterols (TOPS) as a novel food ingredient in low-fat milk products; and
- to include MRLs for the antibiotic neomycin in Schedule 1 of Standard 1.4.2.
The Ministerial Council asked us to review our decision to approve food derived from a genetically modified (GM) insect-protected cotton line COT 102. We completed the First Review in December and reaffirmed our approval of the approved draft amendment. The amendment to the Standard was gazetted in February 2005.
The Ministerial Council asked us to review our decision to permit the use in food of a genetically modified (GM) insect-protected, glufosinate ammonium-tolerant cotton. We completed the First Review in February and reaffirmed our approval of the approved draft amendment. The amendment to the Standard was gazetted in April 2005.
Review of Standards
During the year we commenced work on reviewing a number of Standards.
Review of processing aids and enzymes
In developing the present Code, the Standard from the former Australian Food Standards Code was adopted without change. We did not review the Standard at that time, but the expectation was that we would, once the Code was implemented in both countries as the single food regulatory Code.
The Standard is being reviewed in order to fully harmonise the Australian and New Zealand food regulations under the Code. Two Proposals have been raised. One focuses on the review of enzymes within the Standard, while in the other all processing aids are being considered.
We have prepared an Initial Assessment Report for both Proposals. However, work has been delayed on finalising the Draft Assessment due to other priority work. We expect Draft Assessment Reports to be completed in late 2005.
Review of cyclamate permissions
We have prepared a Proposal to review the use of the intense sweetener cyclamate across the whole food supply. This is in light of a recent survey conducted on behalf of FSANZ on the consumption of intense sweeteners in Australia and New Zealand, which concluded that some consumers of cyclamate products currently for retail sale on the market exceeded the applicable reference health standard, the acceptable daily intake (ADI).
Review of food additives – benzoates and sulphites
We raised a Proposal to consider the use of the food additives benzoates and s