Food standards development
Detailed information on Applications and Proposals processed in 2008-09 is contained in Appendices 1 and 2. Information on FSANZ’s process for assessing Applications and Proposals can be found at Appendix 3.
Ministerial Council Policy Guidelines
The Australian Government, States, Territories and the New Zealand Government are represented by their Health or Food Ministers (as Lead Ministers) on the Australia and New Zealand Food Regulation Ministerial Council. Other Ministers from relevant portfolios such as agriculture, industry, or consumer affairs also participate on the Ministerial Council to ensure a whole-of-Government approach to food regulation.
The Ministerial Council 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, FSANZ must have regard to any written policy guidelines formulated by the Ministerial Council and notified to FSANZ for these purposes.
Ministerial Policy Guidelines notified to FSANZ in 2008-09
No Guidelines were notified to FSANZ in 2008-09.
Standards Development Work Plan
New assessment procedures for Applications and Proposals took effect on 1 October 2007, with the requirements outlined in Part 3 of the Application Handbook.
We continue to assess Applications received, or Proposals prepared, before 1 October 2007 under the procedures in place at that time. Tables 1 and 2 reflect the two types of procedures.
While the number of Applications and Proposals dealt with decreased compared to last year, our workload continued to be characterised by increased demands and complexities. Table 1 shows the number of Applications, Proposals and Potential Proposals on the Work Plan (received or prepared prior to 1 October 2007) as at 30 June 2009, in all Work Plan Groups. Table 2 shows the number of Applications and Proposals received or prepared from 1 October 2007 onwards on the Work Plan as at 30 June 2009.
Table 1: Applications and Proposals on the Work Plan (received or prepared before 1 October 2007)
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 placed on a 3-year rolling Work Plan scheduled for commencement in order of receipt.
Group 3 is for paid applications, on which work commences on receipt of an Initial Assessment fee.
Table 2: Applications and Proposals on the Work Plan (received or prepared from 1 October 2007 onwards)*
*This 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.
General Procedure -This Procedure applies to all Applications or Proposals, unless they are being considered under either the Minor or Major 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 involves such scientific or technical complexity that it is necessary to adopt this Procedure in considering it; or involves such a significant change to the scope of the food regulatory measure that it is necessary to adopt this Procedure in considering it.
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 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: Total Applications received and accepted onto the Work Plan and Proposals prepared
Table 4: Applications and Proposals finalised
*This includes Applications rejected at Administrative Assessment.
Tables 3 and 4 demonstrate, respectively, the trends in projects being accepted onto the Work Plan since 2005 and Board decisions over the same time period. Further information on the above can be obtained from Appendix 2.
Ministerial Council Reviews
The number of 1st Reviews requested by the Ministerial Council continues to fluctuate, but there was a large percentage increase in 2008-09 over previous years.
Table 5: Notification outcomes
*The figures in this column may differ from those provided in the 2007-08 Annual Report as Review requests for matters notified in 2007-08 may have been 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:
(i) it is not consistent with existing policy guidelines set by the Ministerial Council; or
(ii) it is not consistent with the objectives of the legislation which establishes FSANZ; or
(iii) it does not protect public health and safety; or
(iv) it does not promote consistency between domestic and international food standards where these are at variance; or
(v) it does not provide adequate information to enable informed choice; or
(vi) it is difficult to enforce or comply with in both practical or resource terms; or
(vii) it places an unreasonable cost burden on industry or consumers.
We received eight Review requests during the year. Three requests for a 1st Review were for genetically modified commodities based on criterion (iii). The Ministerial Council also requested 1st Reviews of an Application increasing the maximum level of cadmium in peanuts and an Application relating to lutein being added to infant formula. Both of these review requests were based on criteria (ii), (iii) and (vii). A further 1st Review request on an Application proposing to add calcium to chewing gum was based on criteria (i), (ii), (v) and (vi).
In addition, a review was requested on a Proposal which sought to permit and regulate the composition of added inulin / fructo-oligosaccharides and galacto-oligosaccharides to food based on criteria (i), (ii), (iv) and (vi). Finally, a 1st Review request on a Proposal relating to Hydrocyanic Acid in ready-to-eat cassava chips was based on criteria (vi) and (vii).
Additional work requested by the Ministerial Council
The Ministerial Council notified FSANZ of the following matters on 16 December 2008:
1. FSANZ to provide an assessment of the Southampton Study (UK) of food colours and children’s behaviour to Ministerial Council members.
2. FSANZ to provide further information regarding the risk assessment of Application A588 – Voluntary Addition of Fluoride to Packaged Water to the Ministerial Council.
3. FSANZ to assess the difference between consumption data used to prepare its 2007 report on trans fatty acids in the Australian and New Zealand food supply and new data generated by the National Children’s Nutrition and Physical Activity Survey Program and advise the Ministerial Council as to whether this would change the conclusions of the 2007 Report.
FSANZ reviews of food standards
To maintain the currency of provisions in theAustralia New Zealand Food Standards Code, FSANZ reviews food standards on a regular basis, as resources become available. We have identified a number of standards warranting a review – for example, a general labelling review - but have delayed implementation because of the demands of routine standards-setting activities on our resources. This resource constraint has also led to timelines for reviews already in progress being extended.
Review of food additives – benzoates and sulphites
The 21st Australian Total Diet Study in 2005 raised questions about the consumption of the food preservatives benzoates and sulphites in the population, especially by young children. We have since held discussions with industries about the dietary exposure of children to three categories of food – drinks, dried fruit and raw meat sausages.
In 2008-09, we established that industry has significantly reduced the use of these preservatives in drinks and dried fruit since 2003. Discussions are continuing with manufacturers of raw meat sausages to identify industry use of preservatives in raw meat sausages. We will then incorporate the 2007 Australian Children’s Nutrition and Physical Activity Survey data into our dietary modelling.
Information from this work will allow us to decide whether children’s eating habits have changed in the last decade and whether they are consuming too high a level of these preservatives. We should be in a position to recommend changes to the Code, if any, by late 2009.
Review of hydrocyanic acid in ready-to-eat cassava chips
We established that a maximum level of 10 mg/kg for total hydrocyanic acid in ready-to-eat cassava chips was necessary to adequately protect public health and safety. Changes to the Food Standards Code giving effect to this requirement were gazetted during the year.
Review of food allergens
Food allergy is an adverse reaction to food involving the immune system. Approximately 1-2% of adults and 5-8% of children have food allergy. The clinical symptoms of food allergies range from mild to severe and life-threatening reactions. The majority of food allergies are caused by e gg, milk, fish, crustacea peanuts, soybeans, tree nuts and sesame seeds, and their products. The only way for the allergic individual to avoid a reaction is to not eat the food that causes the allergic reaction.
Since 2002, Australia and New Zealand have specific requirements for the declaration of food allergens to consumers on the food label, for packaged products; or at the request of consumers for food sold unpackaged.
FSANZ is in the process of reviewing the allergen regulations, as requested by the Ministerial Council. The review wi ll ensure the regulatory requirements reflect the current scientific knowledge in this field . We are consulting with allergy experts to establish the evidence required to progress the review. As part of the review, we are assessing the significance of lupin as an emerging food allergen. Lupin - a legume related to pea, peanut and soy - has been recently recognised in Europe as a cause of allergic reactions and anaphylaxis.
Foods and food ingredients requiring pre-market approval
To protect consumers from unsafe food, FSANZ carries out safety assessments on certain categories of food and food ingredients before they are approved for sale in Australia and New Zealand. We take a conservative approach to these and other safety assessments. We will not approve a food for sale if there are any doubts about its safety.
Novel foods
Through the Advisory Committee on Novel Foods, FSANZ and its jurisdictional partners provide advice to industry on whether a substance requires pre-approval before its use in Australian and New Zealand foods. We publish the decisions of this advisory committee on our website.
We are examining a request from two manufacturers for the exclusive use of a chemically defined mixture of conjugated linoleic acid triglycerides derived from food-grade safflower oil as novel foods. If the permissions are granted, manufacturers intend to add the mixtures to a range of foods to assist consumers to manage their weight.
We also commenced assessments of three Applications associated with the use of phytosterols in food. The use of phytosterols is already approved for certain products, including table spreads, to assist in lowering cholesterol absorption.
Manufacturers are seeking approval for the use of phytosterols derived from vegetable oils as a novel food ingredient in fruit juice and fruit juice drinks with a minimum 25% juice and tall-oil phytosterol esters in reduced-fat cheeses. Another manufacturer is also requesting a consolidation of the current permissions for phytosterols and their esters within the Code to reflect equivalence of safety and efficacy of the various forms of phytosterols.
In order to assess the merits of these Applications, FSANZ will analyse data on the cholesterol-lowering effects, nutritional effects and safety of phytosterols when added to the respective food vehicles.
We are particularly interested in the cumulative consumption of phytosterols (including current permissions for tall oil phytosterols and phytosterol esters), especially among children, if they are permitted in a broader range of foods. Another area of concern is the potential for altered patterns of consumption of the food vehicle (juice, juice drink and low-fat cheese) by consumers to affect public health.
Genetically modified foods
In 2000, we approved our first genetically modified (GM) food, a herbicide-tolerant soybean. Since then, we have approved a total of 38 GM foods from a variety of crops – cotton, corn, canola, sugar beet, potato, lucerne and rice – as well as soybean. We approved six GM foods during the year, two of which are currently the subject of review by the Ministerial Council. A further five applications are currently under assessment.
The majority of GM food Applications have been concerned with plant commodities possessing ‘first generation’ traits, such as herbicide tolerance and insect protection. We anticipate receiving Applications for commodities possessing ‘second generation’ traits, such as altered compositional content.
As foreshadowed in last year’s report, we arranged for an external peer review of FSANZ’s GM food safety assessment procedures. The purpose of this review was to benchmark our performance in GM food safety assessment against international best practice and to identify areas for enhancement of our scientific capability in this area. The review was undertaken by Dr William Yan from Health Canada.
Dr Yan concluded that the current process used by FSANZ to assess GM food is scientifically rigorous and consistent with international principles on GM food safety assessment. His report noted the expertise and skills of staff in assessing foods derived from gene technology and FSANZ’s lead role in international considerations of GM food safety.
FSANZ has accepted Dr Yan’s recommendations for maintaining its competence and international standing in GM matters and is implementing his suggested improvements to practices.
Processing aids
A processing aid is a substance used in the processing of raw materials, foods or ingredients, to fulfil a technological purpose relating to treatment or processing, but does not perform a technological function in the final food. In 2008-09, we gazetted amendments to the Code for two asparaginase enzymes from different sources, which have been developed to reduce acrylamide formation in processed foods. We also approved two other enzymes, phospholipase A2 and cellulase.
Food additives
A food additive is a substance that performs a technological function in the final food. In 2008-09 we approved the use of steviol glycosides as an intense sweetener and are currently considering the use of ethyl lauroyl arginate as an anti-microbial food additive.
Maximum residue limits (MRLs)
Maximum residue limits in the Code restrict the level of agricultural and veterinary chemical residues in food, while maintaining the effective control of pests and diseases in plants and animals. Regulatory authorities assess the residues associated with proposed MRLs and only permit residues that do not present public health or safety concerns.
During the year, we assessed three Applications and two Proposals to change MRL values and gazetted subsequent amendments to the Code.
Contaminants in the food supply
In 2008-09, we increased the maximum permissible level for cadmium in peanuts. Peanuts are a minor contributor to overall dietary exposure to cadmium for Australian and New Zealand consumers. Following an extensive risk assessment, we concluded that the increase to the maximum level is safe for consumers. It will alleviate any shortfall between domestic and imported supplies of peanuts and still ensure that adequate measures are in place to keep cadmium in the food supply to as low as reasonably achievable.
Fortified foods
Mandatory fortification with folic acid and with iodine
In July 2008, FSANZ approved extending the New Zealand-only standard for mandatory iodine fortification to become a joint standard for both Australia and New Zealand. During this year, therefore, we undertook activities to support of the effective implementation of the new requirements for industry, as well as those for the mandatory fortification with folic acid.
Folic acid is being added to bread-making flour in Australia and, at the time of preparing this report, to bread in New Zealand to further reduce the incidence of neural tube defect (NTD) affected pregnancies. At the same time, salt added to bread during bread-making, is being replaced with iodised salt in Australia and New Zealand to address the re-emergence of iodine deficiency in the population.
In Australia, approximately 300-350 pregnancies are affected by a NTD, like spina bifida, each year, and we estimate that folic acid fortification will result in the number of NTD-affected pregnancies per year being reduced by 14-49 in Australia.
Iodine deficiency has recently re-emerged as a public health concern, with 43% of Australians aged two years and older estimated to be consuming inadequate amounts of iodine. We anticipate that mandatory iodine fortification will reduce inadequate iodine intakes to less than 5% in Australia, with similar results expected in New Zealand.
In Australia, the mandatory requirements for folic acid fortification came into effect in September 2009 and for iodine in October 2009. For New Zealand iodine mandatory fortification became law in September 2009. The New Zealand Government has deferred mandatory folic acid fortification until 2012
In the lead up to the commencement dates, we have been involved in a number of key activities to help ensure the effective implementation of the new regulations. For example, we have developed User Guides, in consultation with government and industry representatives, to help manufacturers, retailers and food enforcement officers interpret and apply the new requirements in Australia.
To assist in informing the general public, we prepared advice to specific population groups which will assist other organisations to develop their own communication and education materials for mandatory fortification. We developed a series of published articles in special interest group newsletters to ensure targeted messages are being provided to specific population groups. Our website also contains information suitable for consumers, health professionals and industry to assist in answering question and explaining issues relating to mandatory fortification.
The Australian Institute of Health and Welfare has the overall coordinating role for monitoring activities for mandatory fortification. We are assisting this monitoring program by tracking key changes in the food supply and by monitoring food consumption patterns and consumer attitudes towards fortified foods.
Voluntary fortification with calcium and with fluoride
FSANZ completed assessments of two Applications seeking permission to add specific vitamins and minerals to new food categories.
The first related to the addition of calcium to chewing gum (containing no more than 0.2% residual sugars). The manufacturer sought permission for this fortified product to provide consumer choice and as an additional dietary source of calcium, given many Australians and New Zealanders do not consume enough calcium to meet their nutritional needs.
We approved the addition of calcium to chewing gum (containing no more than 0.2% residual sugars – commonly referred to as ‘sugar-free’ chewing gum) on the basis that it did not raise any safety concerns, had the potential to assist in addressing inadequate calcium intakes of consumers who chew gum, and may also provide short-term dental benefits. We recommended that no health claims should be allowed.
The Food Regulation Ministerial Council asked us to review our decision to approve this Application, which we did, without change, but with the recommendation that the Ministerial Council may wish to review the policy guidelines relating to the fortification of food. Ministers did not seek a further review in relation to this Application.
The second Application for voluntary fortification involves the addition of fluoride to packaged (bottled) water. The applicant wished to provide a fluoridated bottled water so that people without access to fluoridated water or who preferred to drink fluoridated water would have this choice available to them, while those who preferred unfluoridated bottled water would still have access to unfluoridated products.
Water fluoridation is a contentious issue for some sub-sectors of the community. For this reason, we undertook a comprehensive and robust risk assessment which found that there are no public health and safety concerns for fluoridated packaged water. We also worked closely with government agencies, water experts and dental professionals in Australia and New Zealand who supported our conclusions.
We assessed this Application on the basis of ‘nutritional equivalence’ because fluoridated packaged water is a substitute beverage for fluoridated tap water in terms of its appearance, use and nutritional profile.
On the basis of this assessment, FSANZ approved the voluntary fortification of packaged water with fluoride. This decision enables bottlers to offer fluoridated packaged water to consumers as an alternative to fluoridated tap water or as a source of fluoride for those who do not have access to fluoridated tap water. To provide for informed consumer choice, packaged water with added fluoride will be required to be label to clearly indicate that a product ‘contains added fluoride’.
Food labelling
We develop and amend labelling standards within the context of our statutory objectives. Increasingly, we are asked to assess Applications which seek to provide consumers with information on food labels for reasons of personal choice, rather than addressing particular public health or safety issues.
Applications about labelling for vegetarians, for food produced using gene technology by method of production and for animal-derived products that refer to their methods of production and rearing, are examples of such matters that we considered this year. All required careful consideration. However, none of these Applications were successful since they were outside the scope of FSANZ’s mandate for standards development.
Nutrition and health claims
In response to the Ministerial Council’s request received in June 2008, we have proceeded with the analysis of issues raised for a First Review of the draft standard for nutrition, health and related claims.
However, the Ministerial Council has since requested that a decision on our review response be deferred so that it can be considered concurrently with the outcomes of an independent ministerial review of labelling law and policy being conducted in 2009.
We released a paper for consultation which addressed proposed changes to the draft health claims standard arising from the Ministerial Council’s review request. These changes relate to the approach used for the regulation of general level health claims and the text and structure of the draft food standard. We are continuing with the preparation of our response to the review request during the rest of 2009.
Health advisory labels on packaged alcohol
FSANZ is currently undertaking two pieces of work aimed at assessing the suitability and effectiveness of health advisory statements on alcoholic beverage containers.
The first project is an A pplication to require health advisory statements on the labels of packaged alcoholic beverages advising of the risks of consuming alcohol when planning to become pregnant and during pregnancy. The second was a request from the Ministerial Council for us to consider mandatory health advisory statements on packaged alcohol in relation to high-risk drinking .
In response, w e commissioned the National Drug Research Institute at Curtin University to conduct two reviews on the effectiveness of labelling, the first with a focus on high-risk drinking and the second on pregnancy.
We presented the Ministerial Council with the review report on the effectiveness of labelling in relation to high-risk drinking in May 2009. The Ministerial Council intends to forward this report to the Ministerial Council on Drug Strategy for consolidated consideration by the Council of Australian Governments of broader measures aimed at reducing alcohol-related harm.
In relation to the Application seeking health advisory statements about pregnancy, we are currently analysing the regulatory options, taking into account all relevant evidence and information provided by the commissioned review. FSANZ is cognisant of a number of other activities and initiatives underway in Australia and New Zealand which aim to reduce alcohol-related harm to the foetus.
Exemption of allergen declaration for isinglass
The Beer, Wine and Spirits Council of New Zealand applied for an exemption from the requirement to declare isinglass on the label, when present in beer and wine as a result of its use as a clarifying agent. Isinglass is a processing aid commonly derived from dried swim bladders of certain tropical and subtropical fish.
We concluded that consumption of isinglass-fined beer and wine was not likely to present a risk of allergic reactions in fish-allergic consumers. Following approval by the Ministerial Council, the draft variation of the Code was gazetted in May 2009, thereby giving effect to the exemption.
Food standards for the primary industries
FSANZ has the responsibility for the development of food safety standards for the primary industries to be included in the Australia New Zealand Food Standards Code. The objective is to ensure that food safety is addressed through nationally consistent measures across the entire food chain. We are progressively addressing all primary industry sectors.
These standards – known as primary production and processing standards – apply in Australia only. New Zealand has its own arrangements for primary production.
Following a number of consultations with State and Territory regulators about the implementation of these standards, FSANZ and its jurisdictional partners have developed an integrated model for the development of food standards and consistent implementation. The model envisages a food standard being presented to the Australia and New Zealand Food Regulation Ministerial Council for consideration along with the associated implementation plan and regulatory impact statement.
The model was endorsed by the Food Regulation Standing Committee (FRSC) in August 2008. FRSC agreed that the model would be limited to primary production and processing standards and that the standard for eggs and egg products would provide a pilot.
Eggs and egg products
FSANZ has completed a chemical and microbiological risk assessment which confirmed that use of cracked or dirty eggs and unpasteurised pulp poses the greatest food safety risk to consumers. Outbreaks of food-borne illness attributed to eggs indicate that current measures in the Code to limit the sale of cracked and dirty eggs and to require pasteurisation of all pulp are inadequate.
The draft standard addresses these issues and enables the Egg Implementation Plan Working Group to progress their work. This group has developed a succinct Compliance Plan which will enable the egg industry to understand how they can meet the minimum requirements for compliance with the new egg standard, and how the jurisdictions will implement the standard.
We intend to release the draft standard for public consultation in September 2009 and anticipate that the standard will be completed by mid-2010.
Poultry meat
FSANZ is continuing to work with the chicken industry and the jurisdictions to resolve remaining issues around this project. We anticipate that the standard will be finalised in late 2009.
We completed a nationwide baseline survey to determine the extent of Salmonella and Campylobacter contamination on poultry and poultry meat. The survey, coordinated by FSANZ with the participation of five States and the Department of Health and Ageing, started in mid-2006. The data generated from this survey will assist us to evaluate the effectiveness of risk mitigation control measu res proposed for the poultry meat standard.
We presented the results of the survey to the Implementation Sub-Committee in July 2009.
Raw milk products
FSANZ is reviewing requirements in the Code for raw (unpasteurised) milk products, including raw goat and cow milk and some raw milk cheeses. The Code currently requires milk and milk products to be made from heat-treated (pasteurised) milk. This is regarded as an important public