FOURTH MEETING
Canberra
4-5 December 2002
SUMMARY OF KEY OUTCOMES
Food Standards Matters
Proposal P238 – BSE
The Board considered the Final Assessment Report for a Proposal which seeks to require bovine meat and bovine-derived food ingredients to be derived from animals free from BSE to ensure continued protection of public health. The Board agreed to the Final Assessment Report and the proposed draft variations to the Food Standards Code and the Board’s decision will now be notified to Ministers.
Application A404 - Lactoperoxidase System as a Processing Aid
The Board considered the Final Assessment Report for an Application which seeks to permit the use of lactoperoxidase and sodium (and potassium) isothiocyanate as processing aids on meat with the function of inhibiting bacterial growth. The Board recommends that consumers be informed by appropriate labelling of meat and meat products for the presence of milk proteins. The Board agreed to the Final Assessment Report and the proposed draft variations to the Australia New Zealand Food Standards Code and the Board’s decision will now be notified to Ministers.
Application A443 - Irradiation of Tropical Fruits
The Board considered the Final Assessment Report for an Application which seeks permission for the treatment of specified tropical fruits with machine-sourced electron beams or x-rays to provide an alternative treatment to existing disinfestation techniques (such as chemical treatments) and facilitate access to New Zealand markets for Australian tropical fruit growers. The Board agreed to the Final Assessment Report and the proposed draft variations to the Australia New Zealand Food Standards Code and the Board’s decision will now be notified to Ministers.
Application A458 – Glucose oxidase as a processing aid
The Board considered the Final Assessment Report for an Application which seeks permission for the use of the enzyme, glucose oxidase, as a processing aid from a genetically modified host bacterial strain. The enzyme is to be used in the baking industry to strengthen gluten in dough and, as a processing aid, is not expected to be present in the final food as it is normally inactivated by the high temperatures during baking. The Board agreed to the Final Assessment Report and the proposed draft variations to the Australia New Zealand Food Standards Code and the Board’s decision will now be notified to Ministers.
Proposal P242 – Foods for Special Medical Purposes
The Board considered the Draft Assessment Report for a Proposal which reviews the issues involved in the regulation of foods for special medical purposes. Foods for special medical purposes are principally formulated food products, used under the supervision of medical or other health professionals, for the dietary management of individuals (including children) with either ongoing chronic medical or disability conditions or during acute phases of illness, injury or disease states. They include ‘complete nutrition’ formulas, either consumed orally or through an enteral route (e.g. naso-gastric tube), as well as specialised dietary supplement formulas or foods, and formulas for very low energy diets (VLED) used for weight loss.
The Board agreed to the Draft Assessment Report which will be released in the near future for public consultation, prior to further consideration by the Board.
Proposal P251 – Review of Processing Requirements for Uncooked Comminuted Fermented Meat (UCFM) Products
The Board considered the Draft Assessment Report for a Proposal which reviews the processing requirements for uncooked comminuted fermented meat products such as salami. This Proposal has arisen in response to an MLA (Meat and Livestock Australia Limited)-funded study which found that the current processing requirements were unnecessarily restrictive in order to achieve the specific microbiological outcome as defined in the Australia New Zealand Food Standards Code. The study also found that a substantial rate of non-compliance with the processing requirement exists within the industry.
The study recommended a review of the current requirements to examine whether a less restrictive regulatory measure could be developed that ensures public health and safety, but also facilitates compliance. The Board agreed to the Draft Assessment Report which will be released in the near future for public consultation, prior to further consideration by the Board.
Proposal P266 – Minor Omnibus Amendments to Volume 2 of the Food Standards Code No. 4
The Board considered the Draft Assessment Report for the fourth of several proposals which have been formulated by FSANZ to correct a number of typographical inconsistencies, misspellings, grammatical errors and deletions in Volume 2 of the Australia New Zealand Food Standards Code. The Board considered the issues raised to be of minor significance and complexity and only one round of public consultation need occur. The Board agreed to the Draft Assessment Report which will be released in the near future for public consultation, prior to further consideration by the Board.
Application A446 – Insect-protected and glufosinate ammonium-tolerant corn Line 1507
The Board considered the Draft Assessment Report for an Application which seeks approval for food derived from insect-protected and glufosinate-ammonium tolerant corn line 1507 under Standard 1.5.2 – Food Produced Using Gene Technology.
A mandatory pre-market safety assessment is required under this Standard. The Board agreed to the Draft Assessment Report which will be released in the near future for public consultation, prior to further consideration by the Board.
Application A424 – Fortification of Foods with Calcium
The Board considered the Draft Assessment Report for an Application which seeks permission for the addition of calcium to fruit and vegetable juices, fruit and vegetable drinks, fruit cordial, soups and crispbread/cracker type biscuits. This Application has been assessed according to FSANZ’s statutory obligations and against FSANZ’s regulatory principles for the addition of vitamins and minerals to foods. Specific issues considered by the Board included the eligibility of calcium and the proposed foods for voluntary fortification, the potential risk of excess consumption of calcium, the benefits to consumers of a permission for voluntary addition of calcium to the proposed products (such as additional or alternative food sources of calcium) and the potential for increased calcium intake for the population subgroups with a current intake assessed as inadequate.
The Board agreed to the Draft Assessment Report which will be released in the near future for public consultation, prior to further consideration by the Board.
Application A453 – Trehalose as a Novel Food
The Board considered the Draft Assessment Report for an Application which seeks to permit the use of trehalose as a novel food ingredient. Trehalose is a disaccharide which is found at low levels in certain foods (brewers and baker’s yeast, bread, beer and wine, honey and mushrooms) and exhibits the same technological properties as sucrose with a relative sweetness of 40-45% of that of sucrose. Trehalose is used in a number of countries as a food (USA, South Korea and Taiwan) or food additive (Japan) and has been approved as a novel food in the European Union. The Board agreed to the Draft Assessment Report which will be released in the near future for public consultation, prior to further consideration by the Board.
Application A467 – Alpha-amylase as a Processing Aid (enzyme)
The Board considered the Draft Assessment Report for an Application which seeks approval for the use of an enzyme,alpha-amylase derived from Bacillus stearothermophilus as a processing aid. Alpha-amylase is used as a food enzyme which is involved in one of the stages of producing glucose syrups and maltodextrins used in a wide variety of food industries including confectionery, dairy foods, ice cream, general foods, beverages and health foods. The enzyme may also be used in the alcoholic beverage industry. This alpha-amylase is produced with the use of a non-genetically modified strain of Bacillus stearothermophilus.
The Board agreed to the Draft Assessment Report which will be released in the near future for public consultation, prior to further consideration by the Board.
ApplicationA468 - Maximum residue limits s.36
The Board considered the Initial / Draft Assessment Report for amending MRLs for agricultural and veterinary chemicals in foods. The Board considered the issues raised to be of minor significance and complexity and only one round of public consultation need occur.
The Board agreed to the Initial / Draft Assessment Report which will be released in the near future for public consultation, prior to further consideration by the Board.
Proposal P264 – Review of Gluten Claims with Specific Reference to Oats and Malt
The Board considered the Initial Assessment Report for a Proposal which reviews the need to retain the specific prohibition of gluten claims on foods containing oats and/or malt in clause 16, Standard 1.2.8 and if so, to determine the need to extend the prohibition on oats and malt to include oats and malt ‘and their products’. FSANZ’s primary objective during this review is to protect the health and safety of individuals with Coeliac disease, by ensuring that the regulation of gluten claims adequately reflects current scientific evidence. In addition, this review seeks to ensure that consumers are provided with adequate information to make appropriate food choices for their level of gluten intolerance. The Board agreed to the Initial Assessment Report which will be released in the near future for public consultation, prior to further consideration by the Board.
Proposal P265 – Development of a Primary Production and Processing Standard for Seafood
The Board considered the Initial Assessment Report for a Proposal which seeks to develop a primary production and processing standard for seafood. The primary objective of FSANZ is the protection of public health and safety, while providing for informed consumer choice and prevention of misleading and deceptive conduct. The majority of seafood is considered low risk. However, given the various circumstances under which seafood may be consumed, some types of seafood, such as raw ready-to-eat oysters, are well known to pose significant health risks to consumers. The seafood primary production and processing standard will focus on protecting public health and safety, and will implement this objective through regulatory measures that place minimum impost on the seafood industry.
The Board agreed to the Initial Assessment Report which will be released in the near future for public consultation, prior to further consideration by the Board.
Proposal P271 – Liqueur Definition
The Board considered the Initial Assessment Report for a Proposal which will review the current definition for ‘liqueur’, in Volume 2 of the Australia New Zealand Food Standards Code which is broad enough to allow a large number of products to be classified as ‘liqueurs’ that were never intended to be so classified. If classified as ‘liqueurs’, these products would be considered exempt from certain labelling requirements, such as ingredient labelling, percentage labelling, and nutrition information labelling. Exemption from these labelling requirements was never intended for many of these products.
Different interpretation by producers and retailers of the provisions regulating liqueurs has caused some confusion throughout the industry and resulted in similar products having different labelling information, which is potentially confusing for consumers and enforcement agencies.
The Board agreed to the Initial Assessment Report which will be released in the near future for public consultation, prior to further consideration by the Board.
Application A427 – Caffeine in Carbonated Soft Drinks
The Board agreed to an extension of time for the consideration of this Application. The Applicant has requested permission to add caffeine to all water-based flavoured drinks (carbonated soft drinks and cordials), carbonated fruit drinks and both still and carbonated waters (bottled waters) to a maximum level of 145 mg/L or 200 mg/L (as appropriate). In June 2002, the Applicant modified the request and now only seeks permission to add caffeine to non-kola carbonated soft drinks to a maximum level of 145 mg/L. FSANZ is also waiting on policy guidelines on caffeine from the Ministerial Council. This combination of factors has necessitated extension to the time required to complete assessment of the Application, in accordance with FSANZ’s statutory requirements.
The Application was due to be completed by 2 April 2003. FSANZ will now aim to complete its assessment of the Application by 2 October 2003.
Primary Production and Processing Standards
The Board considered and agreed to terms of reference for the operation of the Board’s Sub-committee on Primary Production and Processing Standards which has been formed to oversee the development of primary production and processing standards.
The Board also considered the feasibility and budget implications of meeting the costs of consumer and industry representatives on the Seafood Primary Production and Processing Standards Development Committee (SDC). The Board confirmed its previous decision to not fund industry and consumer representatives to attend the four planned face-to-face meetings of the SDC, due to FSANZ’s limited resources and in line with Government policy. However, FSANZ would be responsible for costs relating to the numerous teleconferences which would be held.
The Board also considered the legal and operational relationships between the FSANZ statutory standards-setting process and the role of SDCs within that process in the context of the Ministerial Council’s Overarching Policy Guideline on Primary Production and Processing Standards and the Model and Protocol for the Development of Primary Production and Processing Standards by FSANZ. The Board agreed to some internal processes to facilitate information flow and resolution of issues between the SDC and the Board to ensure the views of SDC members are adequately reported to the Board via the FSANZ process.
Update on dietary supplements
The Board was provided with an overview of work being undertaken by FSANZ in relation to the review of food-type dietary supplements (Proposal P235), sports foods (Proposal P236) and formulated beverages (Application A470). At the same time that FSANZ is considering these Proposals and Application, there are a number of external activities operating in relation to dietary supplements and therapeutic goods, in both Australia and New Zealand, which have the potential to impact significantly on FSANZ’s work in these areas and create substantial delays. FSANZ will continue to progress assessment work on these Proposals and Application.
Other matters
Business Plan activities
The Board considered a draft Business Plan and provided feedback to staff to enable further development of the Plan for the Board to consider at its next meeting. The draft Business Plan is being developed in the light of the changed regulatory environment and is expected to achieve savings to help meet the costs of new functions.
Update on A1 A2 milk
The Board considered the latest developments regarding the marketing of A2 milk in New Zealand. FSANZ noted claims that there is a link between A1 milk and certain illnesses (autism, schizophrenia, diabetes and heart disease). FSANZ has not received any applications to amend the milk provisions of the Australia New Zealand Food Standards Code which would involve differentiated regulatory treatment of A1 or A2 milk, nor any research findings which would justify this. FSANZ has noted that further research is in progress and that, while there are some interesting hypotheses being examined, it does not plan any immediate regulatory action on the basis of the available evidence.
Meeting with National Farmers’ Federation (NFF)
The Board met with the Mr Peter Corish, President of the NFF since May 2002 and Mr Peter Arkle, the NFF’s Policy Manager for Rural Affairs. Issues of mutual interest were discussed including FSANZ’s new role in the development of primary production and processing standards and the process of setting maximum residue limits of agricultural and veterinary chemicals. The Board looks forward to working with the NFF, as well as other primary production stakeholders in its new role of developing standards for primary production and processing.
Food Recall Protocol
The Board was provided with a copy of the recently published 5th Edition of theFood Industry Recall Protocol. FSANZ’s mandate is to provide support to industry to enable it to comply with the new Food Safety Standards. To assist in this process FSANZ has revised the Food Industry Recall Protocol to include within it an industry guide on how to write a recall plan.
The purpose of the revised Recall Protocol is to guide food businesses on how to conduct a food recall, and to help food businesses develop a written recall plan so that they can comply with the food recall requirement of Food Safety Standard 3.2.2 . The new Protocol sets out, in a series of steps, how to conduct a recall and explains the roles and responsibilities of businesses and governments when a recall is necessary. In addition to this, the Protocol offers an example of a written recall plan for a food manufacturing business, which may be used as a template or illustration of a recall plan.
Forthcoming Food Composition Program
The Board was advised of plans for a major food composition publication in late 2003 by FSANZ’s Monitoring and Evaluation Program, being prepared as part of an ongoing program of data generation, review and publication. The publication will incorporate a major review of existing data and incorporation of a large amount of previously unpublished data. Both a comprehensive electronic version and a simplified paper version are planned, with guidance on the format of the publication gained from a stakeholder survey conducted in August-October 2002.
Scientific Risk Analysis Framework
The Board gave further consideration to a project that considers the scientific risk assessment processes conducted by FSANZ with a view to preparation of a public document. The new document being developed is seen as an over-arching explanation of FSANZ’s philosophy, broad frameworks and approach. The project aims to: increase understanding and transparency of the principles and approaches underpinning FSANZ’s conduct of risk assessments / analyses; provide context and guiding documentation for more detailed (and more technical) supporting documentation e.g. technical guidelines and procedural papers; rationalise the range of documents already developed or under development by FSANZ that abut the risk analysis processes; identify ‘gaps’; and anticipate future needs.
Update on Evaluation Activities
The Board was updated on progress with evaluation activities and approved the publication on the website of the FSANZ Evaluation Implementation Report on the 2001-2003 Evaluation Strategy. The Evaluation Unit has provided regular updates on progress on the Strategy to the Board, the FSANZ Data and Evaluation Committee and to the FSANZ Stakeholder Advisory Group on Evaluation. Copies of the final reports from three individual evaluation activities are available on the FSANZ website.
FSANZ Fellows Symposium
The Board was advised of details of the FSANZ Fellows Symposium held on Friday, 6 December 2002 in Canberra. The Symposium was to provide an opportunity to bring together the expertise of the FSANZ Fellows, FSANZ Board, staff and invited guests to explore a number of topics relevant to FSANZ’s work. The proposed theme for the second symposium was Assessing the Safety of Our Food Supply – Successes and Challenge.
The Symposium focussed on FSANZ’s risk and safety assessment processes and highlighted emerging trends which may impact on FSANZ’s work.
20th Total Diet Survey
The Board considered the findings of the 20th Australian Total Diet Survey and approved the release of the results. This Survey confirms that the levels of pesticide residues and selected metals and non-metals in the Australian food supply are low and well within health standards.
FSANZ coordinated the survey and relied on those States and Territories involved to arrange purchase and preparation of food samples. The Australian Government Analytical Laboratories carried out all analyses. Sixty-five types of foods were tested for pesticide residues and metal and non-metal content from foods sampled between July 2000 and April 2001. These foods were sampled in different States and Territories and some were sampled at four different times throughout the year.
MRL Policy
The Board considered an update on progress towards devising one streamlined approach to the setting of Maximum Residue Levels (MRLs) for Australia. An inter-agency committee (IAC) is in place, with high-level representation from FSANZ, NRA, AFFA and DoHA, to address this issue.
Food From Cloned Animals
The Board considered background information on issues in relation to foods from products of cloning and cell fusion technologies. Research on cloning and genetic engineering has led to the development of a substantial variety of food and agricultural products as well as pharmaceutical and health related products derived from several types of animals, including cows, sheep, goats, swine, fish, and insects.
The regulatory system for cloned and genetically engineered animals and their products has been the subject of increasing recent attention and discussion among media, policymakers, research scientists and the general public. FSANZ has not received any applications for the approval of GM animal products for sale for human consumption.
Risk Management Framework for Labelling Decisions
The Board considered a draft risk management framework for labelling decisions. The framework brings together a number of principles and concepts established during the development of theAustralia New Zealand Food Standards Code and which have been the subject of stakeholder consultation during the Review of the Code. The risk management framework for labelling establishes a hierarchy of risk and ties a specific category of risk, whether it is scientific, social or economic, with a specific risk management option. The Board will consider this draft paper further at its next meeting.
DIAMOND Fee-for-Service
The Board considered a paper which proposed several options for the future of a FSANZ commercial dietary modelling service using the computer program DIAMOND. FSANZ has completed a one-year pilot of the fee-for-service arrangements for dietary modelling work using the computer program DIAMOND. The Board agreed to a fee-for-service arrangement for DIAMOND considering work requests on a case by case basis.
Promoting Community Involvement Activities
In recognition of the work that the Strategic Development Program has commenced on the organisational systems required to improve consultation with consumers, the Board agreed to the designation of a staff member, working primarily on the strategy as the ‘Community Involvement Development Officer’.
The Board recognised, however, that the current responsibility for answering questions from consumers and others relating to proposed or existing food standards matters, rests with other FSANZ officers, in particular those responsible for managing the assessment of Applications and Proposals and operating the Help Desk.
Code of Practice - Status of Application A411 – Pasteurisation of orange juice
The Board was given an update on the development of a non-mandatory code of practice for guide juice producers on how to comply with their legal obligation to produce safe food. In order to progress the development of a code of practice for juice production in a timely manner, FSANZ has contacted The Australian Fruit Juice Industry to obtain its current Industry Code of Practice. This will enable FSANZ to review the document to determine its suitability to guide juice producers on compliance with their legal obligations to produce safe food.