AUSTRALIA NEW ZEALAND FOOD AUTHORITY REQUEST FOR TENDER FOR

AUSTRALIA NEW ZEALAND FOOD AUTHORITY REQUEST FOR TENDER FOR THE DEVELOPMENT AND MANAGEMENT OF A QUANTITATIVE CONSUMER SURVEY RELATED TO ALLERGEN LABELLING ON FOOD PRODUCTS RFT No 2002/E4 Closing Date: 2pm EST 23 May 2002 This document is available until the closing date. Further assistance regarding this Request for Tender may be obtained from: Janis Baines (Phone 02 6271 2234) 1 Statement of requirement Purpose of the study This labelling study will contribute to an assessment of the implementation of new, stricter labelling standards for foods containing potential allergens. In particular, it will collect baseline data from consumers ‘at risk’ and their carers on their awareness and knowledge of allergens in foods, their ability to identify foods likely to contain allergens and their behaviour towards food selection. It is intended to collect baseline data from September 2002- June 2003. Collection of these data will complement data obtained from general labelling research being undertaken by ANZFA and from label monitoring research.1 A separate tender will be released at a later date for the followup allergen labelling study to enable an evaluation of the impact of the new labelling provisions to be completed. The target population for this specialised survey is consumers ‘at risk’ of anaphylactic reactions to allergens in food products. The population affected by anaphylactic reactions to allergens in food products constitutes a small proportion of the total population in Australia and New Zealand, ~1% for adults and <10% young children (depending on the definition of ‘at risk’ used, see Appendix 1). As this group of consumers includes both adults and children, the target population for the research will also include people who care for young children, for example, parents, other relatives, child care and school staff. This research is to be conducted in both Australia and New Zealand. It is anticipated that the successful tenderer will manage the research in both countries although joint tenderers forming a cooperative consortium arrangement will be given consideration provided that they can ensure that the study is conducted in the same manner in both countries. Background ANZFA has developed an Evaluation Strategy to assess how well the regulatory arrangements (gazetted in December 2000) of the Joint Code are working. The outcome evaluation process will provide information on the effectiveness and appropriateness of food standards and be used to assist in future policy decisions and policy adjustment over time (Figure 1). The allergen labelling research project has been identified as one of the six activities outlined in the Strategy. In this case, ANZFA aims to assess the mandatory food labelling provisions for food allergens contained within the new Food Standards Code against the public health and safety objective described in Section 10 of the Australia New Zealand Authority Act 1991 (Cth) (ANZFA Act), given at Attachment 2. 1 This study by NFO Donovan Research covers awareness and knowledge of labelling issues for consumers and is available on the ANZFA website ANZFA; a related report on labelling issues for other stakeholders is also in process (Request for tender for qualitative research on labelling issues, RFT 2001/E1). Also related are current research projects: ANZFA Request for tender for quantitative research on labelling issues for consumers (RFT 2002/E1); ANZFA Request for tender for establishing an ongoing label monitoring system (RFT 2002/E2) which are available on the ANZFA website at www.anzfa.gov.au/about ANZFA/tenders. 2 A transition period of approximately 2 years from December 2000 before the Joint Code replaces the current alternatives (the Australian Food Standards Code and the New Zealand Food Regulations) allows some time to collect baseline data. However, it is recognised that data collected in this period will not represent a clean ‘before’ and ‘after’ picture. For example, even before the adoption of the Joint Code, some changes were already evident on food labels prior to decisions on the new standards. During the transition period an increasing number of firms in the food industry will switch to the new standard when formulating, packing and labelling products. It is important, nevertheless, to have some baseline data that can be used to benchmark potential changes for stakeholder groups occurring as a result of implementing the new regulatory measures. Figure 1. Assessment of the efficiency, effectiveness and appropriateness of new regulatory measures Inputs Staff and administrative resources Process evaluation (efficiency, effectiveness, appropriateness of food standards setting process) Processes Develop food standards: • draft proposal • seek public comment • draft proposed standard • ANZFSC agreement Outputs Food standards in place, adopted by reference by States & Territories, NZ Output evaluation Outcomes Protection of Public Health and Safety (Objective 1a) Provision adequate information for consumers (Objective 1b) Prevention of misleading or deceptive conduct (Objective 1c) and Standards based on risk analysis using the best available scientific evidence (Objective 2a) Consistency between domestic & international food standards (Objective 2b) Efficient & internationally competitive food industry (Objective 2c) Promotion of fair trading in food (2d) Outcome evaluation (appropriateness, effectiveness of new regulatory measures) NOTE: The Section 10 objectives of the ANZFA Act are given in full in Attachment 2 3 Changes In Labelling There have been substantial changes to labelling provisions in the Joint Code. Some of the provisions in Standard 1.2.3 – Mandatory Warning and Advisory Statements & Declarations are the subject of this study2. The new standard requires three levels of advice for ingredients that may cause adverse reactions. These range from inclusion of the name of the substance in the ingredient list to mandatory advisory statements. Mandatory prescribed statements: A prescribed statement is a specific labelling statement that must be expressed on a label in the exact words and in the format specified in the Code. These statements must always be written on the food label or, where foods are exempt from bearing a label, on the food package or in connection with the display of the food. There are two types of prescribed statements: • • warning statements (no examples to date in the Joint Code); and statements on foods containing genetically modified, novel or irradiated foods or food ingredients. Mandatory advisory statements: The new Code requires mandatory advisory statements on labels of certain foods or when certain substances are present in foods. The specific wording of advisory statements is not prescribed. Where the food is exempt from bearing a label, the statement must be displayed on or in connection with the food or provided verbally or in writing. Examples are statements required about the fact that kola beverages contain caffeine, that food products containing guarana contain caffeine, that unpasteurised milk or milk products have not been pasteurised, or that foods containing aspartame contain phenylalanine. Mandatory declarations of certain substances in food: Certain food ingredients or components, food additives and processing aids must be declared on labels. The inclusion of a substance in the list of ingredients would normally fulfil the declaration requirement. Where the food is exempt from bearing a label, the declaration must be displayed on or in connection with the food or provided verbally or in writing upon the request of the consumer. The labelling provisions for potential allergens are examples of mandatory declarations. Currently not all foods are labelled for the presence of food ingredients that may affect people with allergies or food intolerances. The Joint Code is intended to ensure all of the main foods that may cause allergies – including peanuts, nuts, seafood, fish, milk, eggs, sesame and soybeans and their products will be declared on the label of packaged foods. Previously, only peanuts in packaged foods were required to be labelled. Extent of Declaration This declaration applies when the above listed products are present as: • an ingredient; • an ingredient of a compound ingredient; 2 An ANZFA user guide on this standard titled ‘Warning and Advisory Declarations’ is available on the website (www.anzfa.gov.au). 4 • • a food additive or a component of a food additive; or a processing aid or a component of a processing aid. The objective of mandatory declarations and advisory warning statements are to provide consumers with adequate information such that themselves, their family or carers can avoid a potentially life-threatening adverse reaction to food or an ingredient in food. Summary of proposed research activities This research is part of the overall strategy to assess the impact on stakeholders of implementing food labelling regulations. It is proposed that this allergen labelling research focuses on the consumers ‘at risk’ of anaphylactic reactions and their carers (Figure 2)3. Objectives The research aims to assess the: • • • • level of awareness and knowledge of consumers ‘at risk’ of anaphylactic reactions and their carers, if relevant, of selected labelling provisions in Standard 1.2.3; ability of ‘at risk’ consumers or their carers to successfully identify food containing allergens of interest to them in order to avoid them; behaviour of ‘at risk’ consumers or their carers towards food selection such that changes in behaviour can be measured over time, and contribution of the lack of understanding of allergen labelling to the occurrence of an anaphylactic reaction to the allergens in food specified below. This study will focus on Clause 4, Standard 1.2.3 that lists substances that must be declared whenever they are used in the manufacture of a food. The list includes: • • • • • • crustacea and their products; egg and egg products; fish and fish products; milk and milk products; nuts and sesame seeds and their products; and peanuts and soybeans and their products. This study will not include consideration of declarations of cereals containing gluten and their products, or sulphites content, that are also listed in Clause 4(2) of Standard 1.2.3. Nor will it include royal jelly, bee pollen and propolis, which are not normal/common food ingredients. 3 There is no universally accepted definition of food–induced anaphylactic reaction, but it is generally considered to be a food-induced reaction that involves one or more of the following symptoms: difficulty breathing or throat swelling; generalised urticaria (hives) and/or faintness or collapse (Ewan PW 1993. ABC of allergies: anaphylaxis, BMJ: 316; 1442-5). 5 Study method It is proposed that ANZFA, in conjunction with its expert project group, identifies relevant personnel in Australia and New Zealand to administer a survey questionnaire on allergen labelling at the time of consultation with an allergy specialist. These could include: • staff from hospital units responsible for treating people with potential allergic reactions such as the Royal Prince Alfred Hospital Allergy Unit, Auckland Hospital Allergy Unit and the Children’s Allergy Centre at the Royal Children’s Hospital, Melbourne; and specialists in immunology and allergy in private practice. • An additional source of information may be gained from a postal survey of members of the non-government organizations, such as the Food Anaphylaxis Children’s Training and Support (FACTS) Group and Allergy New Zealand, as a separate subset of the target population in each country. If this option is utilised, it is expected that the successful tenderer will also manage the distribution of this part of the survey via newsletters for these two organisations, as well as data collection, collation, analysis and reporting. ANZFA recognises that selection of a sample via specialist clinics or through members of a support group may result in a non-representative sample of the target group. It also recognises that the proportion of those ‘at risk’ of anaphylactic reactions that have a reaction related to labelling issues is relatively small (Attachment 3) and that the research needs to be designed such that changes in attitudes, knowledge and behaviour in relation to labelling of allergens could be measured over time. The prospective tenderer is encouraged to address these sampling issues in the tender and clarify how they could be addressed. It is anticipated that the successful tenderer will manage the allergen labelling study by keeping in contact with the key personnel administering the questionnaire, will collect and collate data from each research unit on a regular basis, analyse and report on these data on a periodic basis to ANZFA. For children, provisions may need to be made for gaining additional information from carers not present at the time of attendance with the specialist. The successful tenderer will develop the survey questionnaire in conjunction with ANZFA and its expert project team, addressing the research aims outlined previously. The questionnaire will be putt o consumers ‘at risk’ during the period from September 2002 to June 2003. The successful tenderer for this project will be required to consult with the successful tenderers for the ANZFA general labelling survey and the ANZFA food label monitoring survey on aspects that cover allergen labelling issues. Responses to this request for tender should provide information on how the following aspects will be addressed: 6 Methods and Procedures An outline is required of how the tenderer will develop and implement the research project and a demonstration of the approach and strategy that the tenderer would use to manage this project is also required. Information is required in the tender document on the number of subjects required to enable results to be reported on a national basis to a 95% confidence level, given the potential size of the target population. It is intended to undertake a follow-up survey in the future to assess the impact of changing labelling provisions for allergens. In this case the initial sample size should be such that a small change (say 5%) in awareness and knowledge about food labelling, change in behaviour towards food selection or number of anaphylactic reactions to packaged foods can be measured with statistical significance. Specific considerations for sampling procedures are given at Attachment 3. Methodology: • outline of the approach proposed for the study; • advice on the sampling methodology required for the survey of people attending specialist appointments and the postal survey of members of the non-governmental organisations (size of sample, frequency of sampling); • how the data to be collected are to be analysed and reported; and • measures to ensure validity and reliability. Management: • pre-testing and piloting of proposed approach(es); • detailed timetable for each stage; • details of facilitators and their related experience; • training requirements. Ethics • • confidentiality and privacy policy and procedures, with particular reference to the requirements of the Australian Privacy Act 1988 and the New Zealand Privacy Act 1993; and informed consent procedures. Conflict of Interest • any perceived conflict of interests or what might possibly be perceived as a conflict of interest must be declared. 7 Figure 2: Evaluation of allergen labelling standards against objective 1(a) Protection of Public Health and safety Standard 1.2.3 Mandatory advisory statements and declarations Adopted by reference by States & Territories, NZ Output Manufacturers and importers aware of new standards Food standards understood and interpreted correctly by manufacturers and importers and foods labelled correctly Outcomes, arranged as a hierarchy Consumers with known allergies able to select appropriate foods Decrease in food-induced anaphylactic (fatal and non-fatal) reactions that are attributed to lack of information on food labels and/or lack of understanding of food labels Protection of public health and safety 8 Outputs to be produced by the successful tenderer The successful tenderer is expected to: • • • liaise with the ANZFA project team on the design of the allergen labelling survey questionnaire; coordinate the undertaking of the study in both Australia and New Zealand; and attend at least two meetings with ANZFA staff, either in Canberra or at the consultant’s offices, with an additional final meeting for a seminar presentation of the final report for 2002-2003 at the ANZFA Canberra office. Specific outputs The successful tenderer is expected to: • • • prepare and submit a report on pre-testing and piloting of the proposed allergen labelling survey. This report should include clear recommendations for the further development of the questionnaire, if required; prepare and submit an interim report on the allergen labelling survey; prepare a draft final report on all the results of the allergen labelling survey from September 2002 to June 2003 for comment by ANZFA staff, the project team, the ANZFA Data and Evaluation Steering Committee and its Advisory Group on Evaluation; prepare and submit a revised draft final report of the allergen labelling survey for final comment that is of publishable quality for placement on the ANZFA website; submit a final report on the allergen labelling survey that is acceptable to ANZFA; provide 3 hard copies and an electronic copy and of the final report including summary tables; and an electronic copy of the associated raw data files; and present a seminar on the findings of the research to ANZFA staff. • • • Timelines 13.04.02 23.05.02 31.05.02 7.06.02 30.08.02 15.02.03 15 .08.03 28.08.03 19.09.03 Tender document advertised, available from 13.04.02 until 23.05.02 Submission of tenders by 2pm EST Preferred tenderer selected Negotiations to finalise contract with preferred tenderer completed and contract awarded Report due on pre-testing and pilot of allergen labelling questionnaire Interim report meeting with ANZFA Draft final report on allergen labelling research due for comment by ANZFA and its consultative committees Final draft report on allergen labelling research completed and submitted to ANZFA Final report accepted by ANZFA with provision of required hard and electronic copies of report and associated data due 9 Payment for services under the contract will be in four stages: 10% 20% 30% 40% On execution of the contract On provision of an acceptable final pilot report On successful completion of the field work On presentation and acceptance of the final report for allergen labelling, provision of electronic and 3 hard data copies, electronic copies of the raw data, and acceptance of the final report The successful tender will be awarded in the range from $ 30 000-$ 70 000 Australian (incl GST) for the management of the allergen labelling survey. There will be an appropriate reduction in fees should the successful tenderer fail to meet the project deadlines. A term specifying the level of such a reduction will be negotiated between ANZFA and the preferred tenderer and included in the contract. Budget and costs The tender should include total costs, separate costs relating to each of the phases of the research, as well as separate itemised costs (management and project costs including hourly rates for contractor staff and other support staff) associated with the project. At this stage the budget submitted by the tenderer is expected to include an estimate of the cost required for salary replacement of the relevant staff in the allergy units or GP offices responsible for administering the survey. This should be costed as a separate item with the expected number of hours required, assuming these personnel work at a pay rate of $ 40 per hour and the survey takes approximately 4 hours of their time per week. Tenderers are advised to include all associated costs for their proposals, including travel costs associated with team meetings with ANZFA staff and to attend the final seminar presentation. Prices must be given in Australian dollars and must be GST inclusive. Selection criteria The selection of the successful tender by ANZFA will be based on the following criteria (not presented in order of importance): Technical (30%) • demonstrated understanding of the overall objectives of the study; • demonstrated understanding of the approach and methodology for the study; • demonstrated ability to analyse and report quantitative research results; and 10 • relevant qualifications of the proposed consultancy team. Managerial (60%) • demonstrated ability to manage external personnel and the data collection system; • demonstrated ability to conduct quantitative research; • demonstrated ability to deliver within proposed timelines and budget; • project management capability; and • provision of evidence of previous experience with similar tasks, including referees comments. Overall value for money (10%). These criteria are not necessarily exhaustive and ANZFA reserves the right to take into account matters other than those listed when making its evaluation of tenders. Tenderers should be aware that the degree of importance assigned to various selection criteria might change in light of new information that comes to hand during evaluation or negotiation. It is preferred that the tenderer is IQCA or Quality Assurance accredited. The tender response should indicate whether the tenderer adheres to all standards of conduct as indicated by the Market Research Society of Australia (MRSA) Code of Professional Behaviour. The tender To assist in the evaluation of tenders, the following information must be provided: • • • • details including company name and ABN or joint names and ABNs if a joint response and details of any controlling entity; if a joint response, who has prime responsibility and a breakdown of who is supplying each part of the services; the tenderer’s representative for the purpose of this evaluation, contact phone numbers, fax number and address; any proposed subcontractors who will be utilised in the performance of services, including the name and type of services, recent performance and at least 2 referees; detailed project methodology and completion dates, including a clear outline of the proposed sampling and methodology for the research and proposed methods to ensure data quality, and a rationale for the proposed approach; clear articulation of all requirements, including the tenderer’s understanding of the research issues and the broader context; detailed budget; qualifications and experience of personnel assigned to the project, and their responsibilities under the project; details of similar projects the assigned project team have worked on and at least 2 referees, including their contact details; • • • • • 11 • • • • reporting and invoicing formats and procedures; availability; written declaration of any conflict of interest or risk of conflict of interest, which may result from award of the tender; and insurance details. The Response Process Before submitting a tender, a tenderer must read all request for tender documents to understand ANZFA’s requirements. Should a tenderer find any discrepancy, ambiguity, inconsistency, error or omission in this request for tender document or any other information provided by ANZFA, they should notify ANZFA in writing as soon as possible, and in any case before the closing date for the tender so that ANZFA may take any corrective action it considers necessary. ANZFA reserves the right to vary or amend the terms of this request for tender upon giving tenderers timely and concurrent written notice of such variation or amendment. A tenderer’s response to this request for tender will be the sole source of information for the evaluation of the tender. Tenders must be in English and clearly presented. Tenders are liable to be rejected where they are unclear or contain alterations or erasures, incomplete, ambiguous or illegible prices or terms, or insufficient information to enable proper evaluation. Alterations cannot be made to tenders after submission unless it can be clearly demonstrated to the satisfaction of ANZFA that a clerical or keying error has been made by the tenderer. Tenderers may include additional information to describe any additional features of the tender not covered by the requirements. This information, if considered of value, may be considered as part of the evaluation. The tender must be submitted in a format that facilitates evaluation. The recommended format is as follows: • • • • • • Executive summary; Overview of the proposal; Response to the selection criteria; Pricing schedule; Company information; and Supporting information. Tenderers should satisfy themselves as to the correctness and sufficiency of their tender and that the stated costs cover the costs of complying with all the conditions of 12 tender. A tenderer whose tender does not include adequate information as required by this request for tender may not receive further consideration. ANZFA will not be responsible for any expense incurred by a tenderer in preparation of a tender or in tender presentations or negotiations. In particular, ANZFA excludes any liability for costs or damages suffered by affected tenderers by reason of any change in ANZFA’s needs or tender requirements. All documents submitted in response to this request for tender shall become the property of ANZFA. Intellectual property owned by the tenderer or third parties and contained in tender documents will not pass to ANZFA with the property in the tender documents. However, ANZFA is hereby licensed to use or copy that intellectual property to the extent necessary to conduct and efficient tender process. All information made available in response to this request for tender will be treated as commercial in confidence. Neither ANZFA nor its employees or agents represent or warrant either expressly or impliedly that the information contained in this request for tender is accurate or complete. ANZFA shall have no liability for information contained in, or omissions from this request for tender or any written or oral communication transmitted to recipients of this request for tender in relation to the products or services sought. ANZFA accepts no responsibility if a tenderer fails to become aware of matters which would have been apparent from the request for tender or other documents referred to in the request for tender. Where, on the basis of past unsatisfactory performance of contracts or other relevant conduct of the tenderer, ANZFA decides that the tenderer is not a suitable supplier to be involved in the business of ANZFA, the tender may not be considered or taken into account with other tenders received. Tenderers should note that it is Commonwealth policy to exclude from further consideration tenders that have been compiled with improper assistance of employees of ANZFA, ex-employees of ANZFA and/or contractors or ex-contractors of ANZFA, or that have been compiled using information unlawfully obtained from ANZFA. It is also ANZFA policy to exclude from further consideration tenders that have been compiled with the assistance of any other person with advance knowledge of the content of this request for tender, such that it would be unfair to other tenderers to consider their tender. The emphasis in relation to this policy is on improper assistance. It does not preclude tenderers from using ex-employees or ex-Contractors of ANZFA, provided that they have not been involved in the development of the tender and documentation. Closing date and contacts for tenders Tenders must be received by ANZFA by 2pm EST 23 May 2002. Late tenders or letters of intent will not be accepted. The original and two copies of the tender are to be lodged in single-sided A4 loose leaf format. The original is to be marked as the original and each copy sequentially 13 marked with a copy number. An electronic copy of the tender should also be lodged in word or rich text format. In the event of a discrepancy between any copy (including electronic) and the original, the original takes precedence. All pages of the tender must be numbered. Tenders must be addressed as follows and lodged at Level 2, 55 Blackall Street, Barton ACT by the closing date specified above. Ms Janis Baines Evaluation Coordinator Monitoring and Evaluation Program ANZFA Level 2, 55 Blackall Street BARTON ACT 2600 Contact in ANZFA for more information: Communication with ANZFA about this request for tender should be directed to: Janis Baines Evaluation Coordinator Monitoring and Evaluation Program, ANZFA Tel 02 6271 2234, Fax 02 6271 2278 Email: janis.baines@anzfa.gov.au Tenderers are encouraged to raise questions regarding this tender as they arise. Where responses are relevant to all tenderers, the questions and responses will be disseminated to all persons who have requested a copy of this request for tender. Where a question is specific to a tenderer’s response, then these questions and answers will not generally be made available or disseminated. Selection of tender ANZFA has established an evaluation team to oversee and manage the tender evaluation and selection process. Strict confidentiality will be maintained by the team in relation to information received and the proceedings of the team in managing the evaluation and selection process. ANZFA reserves the right to make available to advisers and third parties a copy of any tenderer’s proposals for evaluation purposes only. ANZFA will ensure that any adviser or third party involved in the evaluation process does not have any affiliation with any tenderer. Contract negotiation and execution This tender is expected to result in negotiations for the acquisition of consultancy services under a fixed price contract based on the Commonwealth’s standard form consultancy contract as amended to suit ANZFA’s needs. ANZFA reserves the right 14 to vary and insert additional conditions to the consultancy contract during contract negotiations. ANZFA reserves the right to vary, suspend or abandon this request for tender process and is in no way obliged to accept the lowest cost offer, or any offer. ANZFA reserves the right during contract negotiation, in consultation with the preferred tenderer, to: • • Propose to acquire services in lieu of those offered in the tender; and To vary the requirements as set out in the tender. No tender will be deemed to have been accepted until a contract has been executed by ANZFA and the preferred tenderer. There is no contract, express or implied, until the execution of a formal written contract by both parties. ANZFA reserves the right to negotiate with other tenderers in the event that a contract cannot be successfully negotiated between ANZFA and the preferred tenderer. References: Australia New Zealand Food Authority (ANZFA), (2001) User Guide to Standard 1.2.3 – Mandatory Warning and Advisory Statements and Declarations: Warning & Advisory Declarations, Canberra. Cohen, D (1999) Management of Children with Food-Induced Anaphylaxis, Allergy Unit, Department of Clinical Immunology, Royal Prince Alfred Hospital. Falci, K., Gombas, K.L. & Elliot, E (2001) Food Allergen Awareness: An FDA Priority, U.S. Food & Drug Administration, Centre for Food Safety and Applied Nutrition, February-March. Formanek, R. (2001) Food Allergies: When Food Becomes the Enemy, U.S Food and Drug Administration Consumer Magazine, July-August. Hill, D. Dr & Thiele, L (1995) The Frequency of Adverse Reactions to Foods in Infants and Young Children with Diagnosed Food Allergy, The Children’s Allergy Centre, Royal Children’s Hospital, Melbourne Mullins, R. Dr (2000) Proposal to Establish an Anaphylaxis Training Programme in ACT Schools, Clinical immunology & Allergy, John James Medical Centre, Canberra. Swain, A., Soutter, V. & Loblay, R. (1996) Food Allergy, Proceedings of the Nutrition Society of Australia, 20: 82-5. 15 ATTACHMENT 1 Food allergy A food allergy, or hypersensitivity, is an abnormal response to a food triggered by the immune system. For sensitive individuals, the presence of allergens in food is potentially life-threatening. Currently, there is no cure for food allergy. The only successful method to manage food allergy is avoidance of foods containing the allergen. Fortunately, most consumers are aware of their specific sensitivities and can avoid foods that might result in a life-threatening situation. For example, a person with a peanut allergy may find it easy to avoid whole peanuts. Formulated foods, however, present a separate challenge. In such cases, the individual relies on accurate ingredient labelling. ANZFA, food manufacturers and special interest groups are working to increase public awareness of the seriousness of allergic reactions and to ensure that allergens are appropriately labelled in food products. Allergic reactions are reported to be caused by a large variety of foods, and in theory, any food protein is capable of causing a reaction (Burks & Sampson, pp 246-247). The foods that are most frequently implicated in serious allergic responses are given below, though no order of frequency is implied: • • • • • • • milk eggs fish wheat tree nuts legumes (particularly, peanuts and soybeans) crustaceans and molluscs Some of these foods, such as milk and eggs, are often used as added ingredients in formulated products. Low amounts of allergens from these products may elicit a response and reactions may vary from mild to life-threatening, depending on a person’s particular sensitivity. Potential reactions to wheat are not being considered in this study. The prevalence of food allergy is estimated to be about four to six percent in infancy, one to two percent in early childhood and less than one percent in adults (Swain, Souter & Loblay, 1996, pp 82-5). There have been very few studies that have examined the circumstances surrounding episodes of food-induced anaphylaxis in the Australian setting4. From the information that is available it appears that most patients have experienced definite reactions to the food on previous occasions, however, not all have experienced previous anaphylactic reactions, making identification of those at risk difficult. Further, the majority of instances occur when allergens are unknowingly consumed, often as an ingredient in a 4 There is no universally accepted definition of food–induced anaphylactic reaction, but it is generally considered to be a food-induced reaction that involves one or more of the following symptoms: difficulty breathing or throat swelling; generalised urticaria (hives) and/or faintness or collapse (Ewan PW 1993. ABC of allergies: anaphylaxis, BMJ: 316; 1442-5). 16 manufactured product, such as a biscuit, cake or pastry, despite the packaged product being correctly labelled (Cohen 1999, p5). 17 ATTACHMENT 2 Section 10 Objectives of the Authority in developing food regulatory measures and variations of food regulatory measures5 (1) The objectives (in descending priority order) of the Authority in developing food regulatory measures and variations of food regulatory measures are: (a) the protection of public health and safety; (b) the provision of adequate information relating to food to enable consumers to make informed choices; and (c) the prevention of misleading or deceptive conduct. (2) In developing food regulatory measures and variations of food regulatory measures, the Authority must also have regard to the following: (a) the need for standards to be based on risk analysis using the best available scientific evidence; (b) the promotion of consistency between domestic and international food standards; (c) the desirability of an efficient and internationally competitive food industry; and (d) the promotion of fair trading in food. Review objectives for developing the Joint Code Throughout the review, maintaining and enhancing public health and safety remained the key objective. In addition, the Joint Code aims to: • reduce the regulatory burden on industry by reducing the level of prescriptiveness of food standards. This is intended to facilitate innovation and competition by allowing wider permissions on the use of ingredients and additives, while still meeting the expectations of providing consumers with adequate information; develop standards that are easier to understand and make amendments more straightforward; replace standards that regulate individual foods with standards that apply consistently across all foods or a range of foods; consider the possibility of industry codes of practice as an alternative to regulation; and facilitate harmonisation of food standards between Australia and New Zealand and between Australasian and international standards. • • • • 5 These are the current objectives as listed in the ANZFA Act, as amended in 2000 and are similar to those used in the review of the Australian and New Zealand regulations that were in the Act previously. 18 ATTACHMENT 3 Sampling issues for the allergen labelling survey The target sample for this allergen labelling study is intended to be consumers ‘at risk’ of anaphylactic reactions to allergens in foods and their carers, where relevant. The population affected by anaphylactic reactions to allergens in food products constitutes a small proportion of the total population in Australia and New Zealand, ~1% for adults and <10% young children (depending on the definition of ‘at risk’ used). It is intended to access the target population (those with known allergies) when they attend appointments with allergy specialists, either at allergy units in major hospitals or in GP clinics. An additional source of respondents (those with known allergies and their carers) may be via postal surveys of members of allergy support groups, though members of these organisations may also visit allergy specialists from time to time. Sampling requirements and the period of study required to achieve a representative sample for this research need to be carefully considered. It is possible that virtually all consumers attending the specialist clinics would participate in the survey, so issues of sampling may not arise, though these consumers may not be representative of all those in the population with allergies. However, within the time frame of the research project (September 2002-June 2003), the same person may visit a specialist more than once. This would provide opportunity for follow-up (pre and post labelling change), but also potential for doubling up on interviews (two visits in one review period), which is not desirable. However, the fact that first–time attendees at allergy specialists may not be aware until that visit that they are potentially at risk of food-induced anaphylactic reactions will also need to be taken into account in designing the questionnaire. In the 1995 pilot survey undertaken at the Royal Melbourne Hospital, results indicated that from a sample of 600 people attending the allergy clinic over a one year period, 200 had anaphylactic reactions related to food (Hill and Thiele 1995). Of these, 99 cases were linked to consumption of packaged foods. 85% of these anaphylactic reactions to allergens occurred when the label of the packaged food indicated correctly that the offending substance was present in the food (84 out of 99 cases). In remaining cases, the name of the food ingredient was not understood (eg whey protein not recognised as a milk product) or the small size of the printing on the label was an issue. In one case the product in question had been consumed safely over a number of months but it was discovered on investigation that manufacturing processes had changed resulting in a product contaminated with an allergen. In a 1999 report on a study of children to assess the effectiveness of a specific treatment for anaphylactic reactions to allergens in food, 303 episodes of anaphylaxis occurred in 164 children age 0.9-16 years old (Cohen at al 1999). Potential participants were identified from a list held by the allergy unit at the Department of Clinical Immunology, Royal Prince Alfred Hospital from 1990-1999. Of the 303 episodes reported only 8 of the anaphylactic reactions recorded were attributed to incorrect labelling of food products. Several other reactions occurred when a food thought to be safe was contaminated during manufacturing (eg milk protein from dairy products contaminating a soy milk product). 19 The two studies described above did not collect data on the general level of awareness and knowledge about food labelling nor about the behaviour of consumers in selecting foods they believed to be safe. References Cohen, D (1999) Management of Children with Food-Induced Anaphylaxis, Allergy Unit, Department of Clinical Immunology, Royal Prince Alfred Hospital. Hill, D. Dr & Thiele, L (1995) The Frequency of Adverse Reactions to Foods in Infants and Young Children with Diagnosed Food Allergy, The Children’s Allergy Centre, Royal Children’s Hospital, Melbourne 20