Applications and proposals
Genetically modified foods
The Code now contains 46 approvals for genetically modified (GM) foods derived from canola, corn, cotton, lucerne, potato, rice, soybean and sugarbeet. FSANZ does not expect this crop range to broaden in the next few years, although field trials of other crop species are in progress around the world and it is likely that many of these will reach commercialisation.
Most of the GM foods or food ingredients currently available in Australia and New Zealand are derived from GM crops grown and processed overseas. These crops have mostly been modified to improve their agricultural qualities, such as protection against pests and tolerance to herbicides. However, there have been a number of more recent approvals that have assessed traits such as drought tolerance and compositional changes such as increased content of oleic acid. No GM fresh fruit, vegetables or meat have been approved for sale in Australia or New Zealand.
During 2010–11, FSANZ gazetted four GM foods, derived from soybean, cotton and corn.
Low THC hemp
FSANZ received an application to permit the use of low THC hemp foods in Australia and New Zealand. Hemp is a type of cannabis sativa that contains little or nodelta9-tetrahydrocannabinol (THC)—the active component of cannabis associated with psychotropic effects. At present, the Food Standards Code prohibits all cannabis species from being used as food.
Hemp is not considered to have psychotropic effects because it contains very low levels of THC. We have conducted a safety assessment of hemp foods and have not identified any concerns resulting from their consumption. We released a consultation paper in March and received over 180 submissions. We will continue assessing the application during 2011–12.
Steviol glycosides are the high intensity sweeteners extracted from the leaves of the stevia (Stevia rebaudiana) plant and are approved for use in a number of countries. They have been used in Japan as the main intense sweetener for over 30 years.
The safety of steviol glycosides has been the subject of comprehensive reviews by FSANZ, the FAO/WHO Joint Expert Committee on Food Additives (JECFA), the European Food Safety Authority (EFSA) and the US Food and Drug Administration (USFDA). EFSA concluded in April 2010 that steviol glycosides complying with JECFA specifications were not carcinogenic, genotoxic or associated with any reproductive or developmental toxicity.
We assessed the risks of increasing the allowed maximum permitted level of steviol glycosides in ice-cream, water based beverages, brewed soft drinks, formulated beverages and flavoured soy beverages up to 200 mg/kg and in plain soy beverages up to 100 mg/kg. We concluded that use of steviol glycosides at the proposed levels does not raise any public health and safety concerns, is technologically justified and could result in a better taste benefitting both food manufacturers and consumers.
Irradiated foods cannot be sold in Australia and New Zealand unless they have been assessed and approved. They must be safe, nutritionally adequate and there should be a technological need for the irradiation process, such as providing an effective alternative to the use of chemicals.
The Food Standards Code permits the irradiation of herbs, spices, herbal infusions and selected tropical fruits for food safety or quarantine. Before approvals are granted, FSANZ undertakes a comprehensive review of the safety and nutritional adequacy of the foods following irradiation. Any food that has been irradiated must be clearly labelled, allowing consumers to make informed choices about the product they buy.
In June FSANZ allowed the irradiation of persimmons as a quarantine measure.
Conjugated linoleic acid triglycerides
FSANZ received two applications seeking approval for specific brands of conjugated linoleic acid (CLA) triglycerides preparations as novel foods. The applications sought exclusive permission for fifteen months for their own brands of very similar CLA preparations to be added to various types of foods.
The companies involved indicated the purpose of adding CLA preparations was to assist ‘in weight control programs and diets’ and ‘to assist healthy people as part of their weight management or weight loss regimes’. The levels of CLA to be added were greater than naturally occur in the diet.
We assessed the two applications in parallel due to their similarities. One company withdrew its application before we finalised our assessment.
After careful consideration of the evidence, including submissions from the applicant, FSANZ decided to reject the remaining application. There was insufficient evidence to demonstrate the safety of adding the CLA preparation at the applicant’s recommended level. We posted our reasons for rejection in an assessment report available on our website.
The applicant has filed an application for the Administrative Appeals Tribunal to review FSANZ’s decision.
FSANZ has not yet received an application to amend the Food Standards Code for a novel nanoscale material. We have, however, strengthened requirements in the Application Handbook to ensure applicants provide enough information for us to conduct a risk assessment on a product manufactured using nanotechnologies.
We are aware of a number of reports that estimate that food packaging accounts for the largest share of the current and short-term market applications for nanotechnology in the food sector. Therefore, as part of a broader initiative, we have set up an Industry Advisory Group to provide factual information about food packaging.
The agency continued to be an active participant on the Health Safety and Environment Working Group established under the National Enabling Technologies Strategy for which the Department of Innovation, Industry Science and Research has primary responsibility. We also participate at meetings of the Australian Consortium of the OECD Sponsorship Program for safety testing of manufactured nanomaterials to ensure that we are aware of the latest toxicological research on nanoscale materials.
FSANZ contributed to a review of New Zealand’s regulatory framework for manufactured nanomaterials commissioned by the New Zealand Ministry of Research, Science and Technology. This review was based on the Monash Report, A review of possible impacts of nanotechnology on Australia’s regulatory framework. The review concluded that existing regulatory instruments in New Zealand are generally adequate to manage potential risks associated with manufactured nanomaterials arising from their use in food.
Review of the regulatory management of food allergens
Food allergy affects approximately one to two per cent of adults and five to eight per cent of children. Reactions can range from mild to severe, and can be life threatening. To help allergy sufferers avoid at-risk foods, the Food Standards Code requires a declaration on labels of certain foods and their products—cereals, crustacea, egg, fish, milk, peanuts, soybeans, tree nuts and sesame seeds.
In response to a request by the Ministerial Council in 2006, FSANZ undertook a review of the regulatory management of food allergens. As a first step, we consulted with stakeholders and identified a number of issues to be considered in the review. We then initiated several projects to gather information and build an evidence base that would guide the development of regulatory and non-regulatory options. We also analysed information from medical literature, food industry sources and international regulatory developments.
The review was completed in December 2010 and the Ministerial Council endorsed the outcomes in May 2011.
We are responding to the review recommendations and have already established a Scientific Committee, made up of 10 allergy specialists and scientists, to advise us on food allergen-related issues. By working closely with the Scientific Committee, we intend to integrate emerging findings into the regulatory management of food allergens.
Review of food labelling law and policy
Labelling Logic, the final report from the independent review of food labelling commissioned by the Australia and New Zealand Food Regulation Ministerial Council, was released in January 2011. The report includes 61 recommendations ranging from a conceptual framework to guide decision making on government intervention on food labelling issues, through to specific technical recommendations.
The Department of Health and Ageing is coordinating the whole-of-government response to the recommendations. The Ministerial Council will consider the recommendations in December 2011. FSANZ is providing input to this response and technical advice on specific topics.
Pending this whole-of-government response, we have not commenced any new labelling-related work, but have continued activity on nutrition, health and related claims and on an extension to country-of-origin labelling requirements in the Code. Since one of the recommendations inLabelling Logicconcerns health-warning statements about drinking alcohol during pregnancy, we have deferred further work in this area until the response has been considered.
Country of origin labelling
In October 2009 the Australian Government announced a change in Australia’s Bovine spongiform encephalopathy (BSE) food safety policy for imported beef and beef products setting new requirements for exporters of these products to Australia. The new policy came into effect on 1 March 2010, allowing previously ineligible countries to access the Australian market, subject to meeting specific animal health and food safety requirements.
Current country-of-origin labelling provisions in the Food Standards Code do not include requirements for labelling of unpackaged beef, causing some community concern. To address these concerns the government, in March 2010, asked FSANZ to consider extending these labelling requirements to beef, since present requirements apply to unpackaged pork products, fish and fruit and vegetables .
We are considering extending country-of-origin provisions in the Code to include unpackaged beef, veal, lamb, hogget, mutton and chicken. We commis sioned the Australian Bureau of Agricultural and Resource Economics and Sciences to report on current and potential penetration of imports of beef, lamb and chicken into Australia and have undertaken targeted consultations with major industry and retail stakeholders.
Nutrition and health claims
In May 2011 the Ministerial Council deferred consideration of our response to its request for us to review our decision on a nutrition and health claims standard for Australia and New Zealand until the whole-of-government response toLabelling Logichas been considered. Ministers requested that we provide an interim report on the review response for their meeting in December 2011.
With the support of the Implementation Sub Committee’s Health Claims Working Group, we have been considering a new approach for regulating general level health claims. The Working Group is scheduled to complete this work in the second half of 2011.
Monitoring food labelling
The third phase of a project monitoring food labelling scheduled for this year has been delayed pending the outcome ofLabelling Logicand for resource priority reasons. Following the government’s response to this review, we may resume the next phase of the label monitoring survey to provide a more recent overview of the consistency of food labels. This would provide evidence to support any future amendments to labelling provisions in the Food Standards Code.
Food standards for the primary industries
FSANZ is developing food safety standards for Australia’s primary industries called primary production and processing standards. The aim is to strengthen food safety practices and help traceability in the food industry by covering the entire food supply chain, from paddock to plate.
Eggs and egg products
In 2010–11 primary production and processing requirements for eggs and egg products were approved by the FSANZ Board and introduced into the Food Standards Code. They will take effect in November 2012.
The new provisions, which are legal requirements, will ensure the safety of eggs in Australia by prohibiting the sale of cracked and dirty eggs unless these eggs are being sold to an egg processor for pasteurisation. They place legal obligations on egg producers to identify and control food safety hazards, and obligations on processors to identify and control the food safety hazards associated with processing eggs and egg products. Individual eggs on sale must be stamped with the producers’ unique identification so all eggs can be traced in case of food safety concerns.
Raw milk products
We assess raw milk products as belonging to one of three categories, based on the relative risk they pose.
Category 1 products are defined as those products for which the properties or processing factors eliminate pathogens that may have been present in the raw milk. This would include curd cooked cheeses such as very hard grating cheese.
Category 2 products are those for which the properties or processing factors may allow the survival of pathogens that may have been present in the raw milk but do not support the growth of these pathogens. These products would include Roquefort-style blue cheeses and hard cheeses such as cheddar.
Category 3 products are those for which the intrinsic characteristics or processing factors are likely to allow the survival of pathogens that may have been present in the raw milk and may support the growth of these pathogens, including raw drinking milk and soft mould-ripened cheeses.
FSANZ has concluded that category 3 products present too high a risk to public health and safety to be permitted. Following consultation with our industry, government and consumer advisory group, we have decided to limit the scope of our current work to category 1 products only, deferring consideration of category 2 products because of the need for further technical work. We intend to release an assessment report on category 1 raw dairy products for public comment in August 2011.
Meat and meat products
FSANZ has developed primary production and processing requirements for meat and meat products covering products from farmed cattle, pigs, sheep and goats using extensive and intensive farming, and harvested goats and rendered products for human consumption.
We had intended to consider other animals—covered under existing Australian Standards (for example, buffalo, antelope, camels, deer, rabbits, ostrich, emu, wild game and crocodile meat)—at a later stage. However, following concerns over the possibility of confusion for regulators and industry operating under two sets of standards, we have started a new project to cover animals not considered to be major species.
We have placed a hold on our work on major species while risk assessments are carried out on the remaining meat species. Our industry, consumer and government advisory group has supported this staging of the work, which will enable the development of a draft standard and implementation package covering all species.
Seed sprouts are a germinated form of seeds and beans, such as alfalfa sprouts, onion sprouts, radish sprouts and mung bean sprouts. They are eaten either raw or cooked. Contaminated seed sprouts present an unacceptable health risk to consumers. In recent years, outbreaks of foodborne illness both in Australia and overseas have been associated with eating seed sprouts. The cost to the Australian community from outbreaks in 2005 and 2006 was estimated to be $1.19 million.
FSANZ is working with the seed sprouts industry, governments and consumers to develop a primary production and processing standard. We have held two rounds of public comment and expect the FSANZ Board to consider new provisions in the Food Standards Code later in 2011.
During the year, we commenced a project to establish whether there are unmanaged risks in the horticulture industry and how these risks might best be managed. We released a stakeholder consultation paper outlining FSANZ’s proposed approach to fresh horticultural produce. We sought feedback from farmers, packers, processors and wholesalers, as well as state and territory departments and other interested parties. This consultation will help us to develop the most practical, evidence-based and cost-effective measures to manage food safety risks in horticulture.
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