2019 Food Industry Guide To Allergen Management And Labelling

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2019Food Industry Guide toAllergen Managementand LabellingFor Australia and New ZealandA partnership document of the Australian Food and Grocery Council and the Allergen Bureau

Food Industry Guide to Allergen Management and LabellingThe Allergen Bureau is the peak industry bodyrepresenting food industry allergen management inAustralia and New Zealand. Our mission is to provideconsistent, science-based, allergen risk assessmentand labelling. The Allergen Bureau has developed andprovides key best practice allergen management andlabelling guidance for the food industry, particularly theglobally recognised VITAL (Voluntary Incidental TraceAllergen Labelling) Program - a standardised allergenrisk assessment process for food industry. The AllergenBureau was established in 2005 and operates on amembership basis.The AFGC is the peak industry body for Australian foodand grocery suppliers. Founded in 1995, our vision isto create a thriving and trusted food and grocery supplyindustry delivering jobs, economic growth and helpingpeople live well.www.afgc.org.auTel: 61 2 6273 1466www.allergenbureau.netTel: 61 437 918 959DisclaimerMaterial included in this publication is made available on the understanding that the Australian Food and Grocery Council (AFGC) and the Allergen Bureau are not providing professional advice, that theFood Industry Guide to Allergen Management and Labelling is intended as a guidance document which may assist in a total approach to allergen management, allergen communication and labelling, andthat using the Food Industry Guide to Allergen Management and Labelling does not guarantee that a consumer will not suffer an allergic response.If you intend to use information provided in this publication, you must exercise your own skill, care and judgement, evaluate the accuracy, completeness and relevance of any information or recommendationfor your purposes, and obtain your own professional advice.The AFGC and the Allergen Bureau provide no warranty and do not guarantee the accuracy or completeness of the material contained in this publication, or in any recommendation obtained from it,including regarding compliance with food labelling laws and regulations or the management of the risk of product liability and personal injury.The AFGC and the Allergen Bureau disclaim all liability to any person in respect of any loss or liability suffered in connection with the reliance, whether wholly or partly, on any information contained in thispublication.Copyright The Australian Food and Grocery Council 2019Copyright Allergen Bureau Limited 2019Management of the GuideLegislative ComplianceThe AFGC maintains this document with the support and input of the AFGC Allergen Forum andThis document is intended as a guide only, the relevant legal requirements may be found in theAllergen Bureau. The AFGC will update this document from time to time so it is recommendedfollowing Acts and other laws applicable in each jurisdiction:that companies check the AFGC (www.afgc.org.au) or the Allergen Bureau(www.allergenbureau.net) websites regularly for the most recent version.Terms of UseRefer tohttps://www.afgc.org.au/terms-and-conditionsand toFor Australiathe Australia New Zealand Food Standards Code;the Australian Competition and Consumer Act 2010 (Cth)For New Zealandthe Australia New Zealand Food Standards Code;Consumer Guarantees Act 1993 (NZ);Fair Trading Act 1986 ite-terms-of-use.2

Food Industry Guide to Allergen Management and LabellingContents1.2.3.4.INTRODUCTION 41.1Food Allergy & Anaphylaxis 61.2Coeliac Disease 81.3Food Intolerance 8REGULATORY REQUIREMENTS92.1Food Acts & Product Liability Law 92.2Australia New Zealand Food Standards Code2.3International Food Allergen Regulation 15ALLERGEN MANAGEMENT10163.1Allergen Management 163.2Allergen Risk Review 183.3Allergen Analysis 19ALLERGEN LABELLING & COMMUNICATION 204.1Allergen Labelling Best Practice 214.1.1Recommended Allergen Labelling Format 224.1.2Composition of Allergen Labelling Information244.1.3Presentation of an Ingredient List254.1.4Presentation of an Allergen Summary Statement264.1.5Precautionary Allergen Labelling (PAL) 274.1.6The Voluntary Incidental Trace Allergen Labelling (VITAL ) Program284.2Label Artwork Approval & Signoff 294.3Allergen Free Claims 304.4Allergen Communication 315.FOOD RECALLS 346.APPENDIX7.366.1Alternative Labelling Formats 366.2Management of Reports of an Alleged Allergic Reaction6.3Recall Case Studies 4037ENDNOTES 423

Chapter 1: Introduction1.INTRODUCTIONManaging the risks associated with the presence offood allergens in ingredients and products is a majorfood safety challenge faced by food producers andsuppliers at all levels of the supply chain. Incorrect orunclear allergen information can be a life or death issuefor individuals living with food allergy.All food companies (including manufacturers, marketersand importers) have a responsibility to manage boththe intentional and unintentional presence of allergensin food products, and require stringent and robust foodsafety management practices, so they can sell productswith a known allergen status.Food companies have a responsibility to fullyunderstand the allergen status of their food products.Knowing the allergen status of a food includesdetermining whether allergens are or are not present.If present, it involves determining what those allergensare, if the allergen is an ingredient, food additive orprocessing aid, or is present due to cross contact.Allergen management and labelling practices are tobe kept up to date and reviewed periodically to ensurecompliance.Clear and accurate information about the allergenstatus of each product should be communicatedthrough labelling, specifications and electronic media toenable consumers with a food allergy to make safe andinformed food choices.These requirements are the same whether the productor ingredients are manufactured or sourced in Australiaand New Zealand or are imported.About the Food Industry Guide toAllergen Management and Labelling(Guide)This document describes industry best practice forthe management of allergens, allergen labelling, andallergen communication. In this Guide, ‘allergens’ arethe foods or substances that are listed in the AustraliaNew Zealand Food Standards Code (the Code) Section1.2.3—4 Mandatory declaration of certain foods orsubstances in food.This Guide provides: an overview of food allergy and foodintolerance a description of the requirements outlined inthe Code regarding food allergens that requirelabelling in Australia and New Zealand information about international food allergenregulations guidance on the management of food allergensin the manufacture and supply of foodingredients and finished products information on analysis for allergens best practice guidance for allergen declarationand communication, including the application ofthe VITAL (Voluntary Incidental Trace AllergenLabelling) Program for risk assessment andlabelling of cross contact allergens. The VITALProgram is a resource of the Allergen Bureau guidance on the management andcommunication of a change in allergen statusof a food product guidance on the management of reports inrelation to alleged allergic reactions to a foodthe company has supplied information about food recalls.4

Food Industry Guide to Allergen Management and LabellingAlthough some labelling considerations for allergen freeclaims are included in this Guide, it is not the intentionof this document to describe the risk managementrequirements that deliver food products which makesuch claims.This Guide was developed through a collaborationof the Australian Food and Grocery Council (AFGC)and the Allergen Bureau (which are not-for-profitorganisations). The information was drawn fromcollective industry expert knowledge and is supportedby additional resources and information freely availableon both the AFGC (www.afgc.org.au) and AllergenBureau (www.allergenbureau.net) websites.ScopeThis Guide is relevant to all sectors of the foodindustry involved in the supply, handling, production,distribution and sale of foods including the following: food ingredient manufacture and supply – both localand imported manufacture of packaged food for bulk sale,including business to business manufacture of packaged finished product (retailready) imported packaged foods.This Guide is relevant to all sectorsof the food industry involved inthe supply, handling, production,distribution and sale of foods.5

Chapter 1: Introduction1.1FOOD ALLERGY & ANAPHYLAXISAn allergy is an overreaction by the body’s immunesystem to a normally harmless substance. Foodsor substances that can trigger an allergic reactionare called allergens. In most cases, food allergensare proteins and a food may comprise one or moreallergenic proteins. For example, egg allergenicproteins have been found in both egg white and yolk,and egg white is known to contain several differentallergenic proteins. People who are allergic to eggwhite may not be allergic to yolk. Similarly, cow’s milkcontains allergenic proteins in the whey fraction anddifferent allergenic proteins in the casein fraction1.Individuals may be allergic to only one milk protein ormore.Allergic reactions to foods are characterised by therapid release of powerful cellular chemicals, suchas histamine, released by mast cells once the bodyrecognises the allergen has been eaten. This allergicreaction most often occurs within minutes, though cantake place up to two hours after ingestion.Food allergies are usually mediated by immunoglobulinE (IgE) antibodies and can be confirmed by a skin-pricktest or blood test. Diagnosis of an allergy should beperformed by a specialist allergy medical practitioner.A medical practitioner needs results from clinical testsindicating the presence of IgE antibodies to a particularallergen, as well as the patient’s medical historyinvolving an allergic response to the food, to make adiagnosis of a food allergy to a particular substance.An allergic reaction may occur after ingestion offood containing an allergen, even in small amounts.This can result in a mild/moderate allergic reactionor anaphylaxis, a potentially life-threatening allergicreaction. A mild or moderate allergic reaction can quicklybecome life threatening.Food allergy symptoms vary in nature and severitybetween individuals. Signs of a mild to moderateallergic reaction can include: swelling of the lips, face, eyeshives or weltstingling mouthabdominal painvomiting.If an individual is allergic to a food, avoidance of theallergen is the only way to manage the condition.Worldwide, there is limited data that describe theprevalence of food allergy. One 2011 Australian studyreports that over 10% of 12-month-old infants havefood allergy (of which raw egg is 8.9%, peanut is 3.0%,sesame is 0.8% and cow’s milk is estimated at 2.7%)2.A 2015 study of hospital admissions in Australia, showsthat the prevalence of food allergy is increasing inchildren and teenagers between 5 and 14 years ofage and that overall there appears to be an increasein food allergy prevalence in Australia, the UK and theUnited States over the past ten or more years. Althoughfood allergy is predominantly found in Westernisedcountries, it is expected that the prevalence willcontinue to increase globally3.The Australasian Society of Clinical Immunologyand Allergy (ASCIA) estimates that food allergyoccurs in around 1 in 20 children and in about 2 in100 adults.Allergy to cow’s milk is more common in infants.In Australia and New Zealand, approximately 2%of infants have milk allergy. About 80% of childrenwith cow’s milk allergy can grow out of the allergy ataround the age of 3-5 years.Allergy to peanut and tree nut usually begins ininfants and young children, although adults can alsodevelop the allergy. In Australia, peanut allergy hasbeen shown to occur in 3% of infants. About 20%of people with peanut allergy grow out of it, or thesymptoms lessen, for others the allergy can becomeworse with time.Seafood allergy is not common in young childrenbut can occur in teenagers and adults in about1% of the population. It has been reported thatapproximately 20% will grow out of the allergy overtime.Limited information is available about theprevalence of lupin food allergy with 8 allergicreactions reported in South Australia from 20042009.ASCIA www.allergy.org.au6

Food Industry Guide to Allergen Management and LabellingMore than 170 different foods and ingredients havebeen identified as potential allergens4. However,globally, most allergic reactions are attributable to asmall number of foods which include cereals containinggluten, crustacea, eggs, fish, peanuts, soybeans, milk,tree nuts5 and, in Australia and New Zealand, sesameand lupin. Allergens of importance can vary by globalregion, for example, buckwheat is an allergen in Japanand Korea.The Code requires the mandatory allergen declarationof ten (10) food allergens and sulphites (refer to Table2: Mandatory declaration requirements for certain foodsor substances in Australia and New Zealand in thisGuide). Although it is recognised that there are manyother foods that may cause an allergic reaction, thesedo not require mandatory declaration for foods sold inAustralia and New Zealand.It is generally acknowledged that it is unrealistic forfood manufacturers to manage every potential allergen.In this Guide, the management of allergens is focussedon those listed in the Code. However, the principles canbe applied to any other food allergen (such as allergensof importance in other global regions). wheeze or persistent coughdifficulty talking and/or hoarse voicepersistent dizziness or collapsepale and floppy (young children).Individuals who have been diagnosed with severeallergy are prescribed an adrenaline autoinjector (e.g.EpiPen or other brand) for immediate administrationwhile an ambulance is called.A person that has experienced anaphylaxis previouslyis more likely to have another anaphylactic reactionwhen exposed to the same allergen. Similarly,individuals with a mild/moderate reaction may progressto anaphylaxis with a subsequent exposure.Death from Anaphylactic ReactionThe consequence of an allergic reaction to a foodcan be tragic – in late 2013, a young boy died afterbecoming ill after dinner one evening. The childhad an known allergy to cow’s milk and consumeda coconut drink which was subsequently found tobe incorrectly labelled, as the product contained anundeclared cow’s milk ingredient.This tragic death was investigated by the Coroner’sCourt of Victoria and the findings handed down inJune 2016. The coroner found that:Anaphylaxis“On the evidence available to me, I find that[name], who was highly allergic to dairy milk, diedafter ingesting ‘Brand X Natural Coconut Drink’, aproduct that has been imported from Taiwan andmislabelled, so as not to declare that it containeddairy.”7A severe allergic reaction (anaphylaxis) to food isdefined by the involvement of the respiratory systemand/or the cardiovascular (heart and circulation)system. The incidence of anaphylactic reactions to foodin allergic individuals is increasing. The condition canbe fatal if not treated with adrenaline within minutes.Signs of anaphylaxis, as stated on the ASCIA6 ActionPlan, can include:There have since been multiple recalls of importedcoconut drinks and coconut milk powders thatcontained undeclared milk in Australia, NewZealand, and throughout the world. In response tothis, in 2018, new laws were created in Australiawhere Victorian hospitals are required to notify theDepartment of Health and Human Services of allanaphylaxis presentations. difficult/noisy breathing swelling of the tongue swelling/tightness in the throatSome coronial investigation reports that are relatedto food allergy are available on the Allergy &Anaphylaxis Australia website.7

Chapter 1: Introduction1.2COELIAC DISEASECoeliac disease is a genetic immune disease causedby gluten, a protein in wheat, rye, barley, oats andtheir various subspecies and hybridised varieties.Coeliac Australia report that coeliac disease affectsapproximately 1 in 70 Australians, however, around80% of this number remain undiagnosed8. Coeliacdisease can develop at any age, from infancy (whengluten is first introduced to the diet) to senior years.When people with coeliac disease eat gluten, aninappropriate immune reaction causes inflammationand damage to the small bowel (intestine) andother areas of the body. Accidental ingestion is notimmediately life threatening (as can be the case inthose with food allergy). Symptomatic reactions canvary considerably, and may include diarrhoea, nausea,vomiting, abdominal pain, cramping, headache, andfatigue. Those with the condition are also at riskof complications. There is no correlation betweensymptoms and bowel damage so even if asymptomatic(patient displays no obvious symptoms), inflammationand damage can still occur if gluten is ingested.People with coeliac disease, irrespective of the severityof their symptoms, need to adhere strictly to a glutenfree diet.1.3FOOD INTOLERANCEA food intolerance is an adverse reaction to a foodbut, unlike food allergy, it does not involve the immunesystem. Food intolerances can be dose-relatedand include reactions to non-protein substancesin foods such as some carbohydrates, chemicals,food additives, toxins and irritants. Diagnosis of foodintolerance can be difficult and is usually managed bythe use of an elimination diet. Signs and symptoms of afood intolerance can occur many hours after ingestionand not within the first two hours like a food allergyreaction. Symptoms can include: hives, eczema and other itchy skin rashesmouth ulcers, reflux, bloating, stomach aches,constipation and/or diarrhoeaincontinence and/ormigraines or headaches.Some people can have an intolerance towardssulphites which can cause allergy-like reactions, mostcommonly asthma symptoms in those with underlyingasthma9. A small number of people with asthma canexperience wheezing, chest tightness and coughing10 iffoods containing sulphites are consumed.Wheat allergy and glutenintolerance are not the same.Although wheat containsgluten, individuals can beallergic to wheat but notallergic to other cereals thatcontain gluten.8

Food Industry Guide to Allergen Management and Labelling2.REGULATORYREQUIREMENTSAustralia and New Zealand share a multi-jurisdictionalfood regulatory system that is based upon harmonisedfood standards which assist industry by reducingcompliance costs and trade barriers. Food StandardsAustralia New Zealand (FSANZ) develop andadminister the Code. Various food regulation authoritieswithin Australia and New Zealand are responsible forits interpretation and enforcement. A food companyneeding information on complying with the Code shouldcontact their local enforcement agency for advice. Alist of food enforcement contacts is available on theFSANZ website.2.1FOOD ACTS & PRODUCTLIABILITY LAWAustraliaNew ZealandUnder the New Zealand Food Act 2014 (Food Act),persons who trade in food must ensure the food is‘safe’ and ‘suitable’ and compliant with the Code. InNew Zealand, the Ministry for Primary Industries (MPI)is responsible for enforcing the Code and Food Act.Local councils also assist with enforcing the Food Actthrough Food Safety Officers (Officers)11.Officers have a wide range of enforcement tools,including: issuing infringement notices (instant fines) forminor offences issuing improvement notices and notices ofdirection (e.g. require businesses to improve foodsafety) interrupting operations if necessary, to assist intheir investigations issuing compliance orders that can be issued by aDistrict Court to compel business operators to takecertain actions.Within Australia there are several Commonwealthand s

information about food recalls. 1. INTRODUCTION Managing the risks associated with the presence of food allergens in ingredients and products is a major food safety challenge faced by food producers and suppliers at all levels of the supply chain. Incorrect or unclear allergen information can be a life or death issue

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