Guidance On Food Allergen Management For Food Manufacturers
Guidance on Food Allergen Managementfor Food ManufacturersJanuary 2013
IndexForeword . p. 03Introduction .p. 042. Risk Management Processes . p. 062.1. Overview . p. 062.2. People . p. 082.3. Supplier Management . p. 102.4. Raw Materials Handling . p. 112.5. Equipment and Factory Design . p. 122.6. Production Process and Manufacturing Controls . p. 132.7. Consumer Information . p. 152.8. Product Development and Change . p. 162.9. Documentation and Record-Keeping . p. 173. Cleaning and Cleaning Validation . p. 183.1. General . p. 183.2. Cleaning Methods . p. 204. Analytical Methods and their Application . p. 225. Key Principles of Allergen Risk Management . p. 246. Glossary . p. 26Annex 1: Background on Food Allergies and Intolerances . p. 32Annex 2: Allergen Risk Analysis and Management . p. 38Annex 3: Allergen Labelling . p. 56Annex 4: Allergen Change Over (Cleaning/Flushing) Validation. p. 64Annex 5: Allergen Analysis . p. 70Annex 6: Gluten-free Products . p. 80p // 2
ForewordJesús Serafín PérezPresidentScientific understanding of the risk from food allergens hasgrown over the last 20 years and continues to develop. Foodallergies and intolerances are now well recognised as a foodsafety issue, which must be managed. Understanding ofthe risk from allergenic foods remains inconsistent acrossthe industry. Managing the risk to allergic consumerswould benefit from an improved consistency of allergenmanagement, methods and practices.The food industry has made significant efforts inimplementing allergen risk management practices.Whilst reducing unintended exposure of allergicconsumers to allergens, this has also led to the spread ofadvisory labelling. This can reduce the choices availableto allergic people, resulting in frustration and risktaking behaviour, which negates its purpose. Advisorylabelling on possible cross-contact with allergens isjustifiable only on the basis of a risk analysis applied toa responsibly managed operation. Approaches for theapplication of advisory labelling need to be developed.In order to manage their condition, consumers with foodallergies and food intolerances must be fully informedabout the nature and composition of the foods they arebuying. Changes in food labelling legislation have ledto significant improvements in the labelling of allergenicingredients in foods. However, unintended allergenicconstituents can be present in foods as a result ofmanufacturing and other operations.Allergenic foods possess some uniquecharacteristics as a food safety hazard,which need to be considered in assessingand managing the risk:Allergenic foods are harmless to themajority of consumers.Consumers intolerant or allergic todifferent foodstuffs can react to a widerange of amounts of allergenic foods.These amounts can vary considerably(frommicrogramstograms)depending on the individual’s personaltolerance, their health and their currentmedication. A few acutely sensitiveconsumers can react to very low levels(low micrograms), albeit mildly.Although much work has been doneto determine thresholds / no adverseeffect levels and use them in foodsafety risk assessment, agreementbetween stakeholders has not yetbeen reached on how to interpret thisinformation in public health terms.p // 3
IntroductionThis Guidance document was prepared by FoodDrinkEurope to provide sound, evidence-basedand consistent information on good practice in risk management of allergenic foods and certain foodintolerances (hereafter referred to as ‘allergen management’) for food producers of foodstuffs intended forsale to the general population. By harmonising and disseminating good practice across the European foodindustry at all levels, this Guidance will ensure a consistent understanding of, and approach to, managingallergens and certain food causing intolerances to a high standard throughout the European food industry.This will help minimise the risk to allergic consumers and enable them to make informed product choices.This Guidance sets out general principles that can beused to manage specific foodstuffs causing allergy orcertain intolerances in different situations. The focusof this Guidance is the production of prepacked foodsintended for sale to the general population. However,the general principles also apply to non-prepackedfoods. Actions that may be appropriate in each specificsituation need to be determined by each individual foodbusiness. Different sectors of the food industry mayhave specific requirements that build on the approachset out herein.It is not the intention of this document to describerisk management requirements that deliver foodproducts which make a claim that they are intended forallergic consumers.Special thanks and acknowledgment go to the FoodStandards Agency (FSA, UK) for agreeing to theuse of its “Guidance on Allergen Management andConsumer Information” (July 2006) as the basis forthis document. Furthermore, express acknowledgmentand appreciation must be given to Sylvia Pfaff, FoodInformation Service Europe (FIS), who oversaw thedrafting of this Guidance from its inception and did muchin compiling the information referenced in this section.p // 4Additionally, the following documents were consideredin the drafting of this Guidance:FoodDrinkEurope Guidance document on thepractical application of the Directive 2003/89/EC oningredient and allergen labe lling (Version 08/2005).The FDF Dried Foods Industry Guidance on AllergenControl and Risk Management (Version 1.02, August2008).The Swedish Food Sector Guidelines formanagement and labelling of food products withreference to Allergy and Intolerance (VersionAugust 2005).The Federalimentare Guidelines on the Labelling ofAllergens (Version 2, 6 November 2009).Research results from projects such as: “The Basis,Prevalence and Cost of Food Allergies across Europe”(EuroPrevall FOOD-CT-2005-514000).Recommendations re: analytical testing from theMoniQA EU Network of Excellence.International Life Sciences Institute, ILSI EuropeConcise Monograph Series - Food Allergy.
ScopeThis Guidance has been drafted for the management in any food manufacturing environment - of allergenicfoods and substances (“allergens”) identified in EUlegislation.Food companies have a responsibility to establish afood safety management system to comply with legalrequirements. Allergen Management should be anintegrated part of food safety assurance strategiesand should consider the risk from food allergenstogether with other food safety risks. It should bebuilt into operational standards for a company’s ownmanufacturing, for third party manufacturing performedon behalf of the company and be incorporated into allraw material supply standards.This Guidance recognises that small and medium-sizedenterprises (SMEs) may not be in possession of the samecapabilities and resources as larger food companies.It must be stressed that whilst this Guidance goes nofurther than the relevant legislation prescribes, it seeksto embody good practice in allergen risk managementin addition to providing practical recommendationsto guide SMEs, amongst others, through differentsituations relating to specific allergenic substances. It isultimately for each and every food company to decideon the application of the Guidance.p // 5ObjectivesThis document aims to:provide general guiding principles to allfood operators regarding food allergenrisk management, which can be readilyadapted to different product process andproduction facility designs.provide information about food allergyand food allergens to indicate theirimportance as food safety hazards.
Risk ManagementProcesses2.1 OverviewThe need to manage potential risks from allergenic foods in a food production environment is universallyaccepted by all stakeholders in the food supply chain. This responsibility may be met in several differentways, for instance, via a Prerequisite Programme and then via integration in a business’ HACCP Programme.Allergen management in food businesses shouldThis evaluation should be carried out by personnelbe seen as an integral part of existing food safetyappropriately trained in allergen management.management rather than a completely new system.An effective allergen management system mustDocumented procedures for the control and preventionconsider all operations from sourcing of raw materialsof contamination must be in place and visible orthrough manufacturing and packaging to the finishedreadily available to all employees in the work area. Theproduct, including new product development.procedures should contain information about:Food businesses should operate in line with GoodManufacturing Practice (GMP) principles. This requiresa commitment to ensuring that products meet foodsafety, quality and legal requirements, using appropriatemanufacturing operations controls, including effectivefood safety and quality assurance systems. Adherenceto existing GMP controls will be essential for allergenmanagement, for example, avoiding cross-contactby segregation using cleaning, separate utensils, linededication, equipment and storage dedication, etc.Risk management starts with risk assessment, which,Product development guidelines in terms of allergens.Good hygiene, for example, rules regarding clothing,hand-washing and hand contact with foods.Cleaning of premises, equipment and tools.Handling of rework materials, for example, theconditions under which such products may be used.Waste management, for example, how waste shouldbe labelled and kept separate from rework.Situations where potential cross-contamination canfor allergens, requires consideration of, at a minimum,occur between raw materials, products, production(powder, liquid, pieces, etc), as well as the amount of anyfor preventing this.the likelihood that they are present, their physical formallergen present. Risk management must encompassevery component of the supply chain, from raw materialssupply specifications to the sale of the finished productand including product design and development.p // 6lines or equipment, and each employee’s responsibilityProduction scheduling.Labelling of raw materials, semi-finished goods andfinished products.
Changes to any process within a food productionfacility, or introduction of a new raw material orproduct, can affect allergen cross-contact risks forother products manufactured at the same site. Movingproduction of a product to another site may also alterthe allergenic risk associated with it. Any such changeswill therefore require a re-assessment of the originalrisk for all potentially affected products and, if required,application of new risk management measures. Anynew relevant risk identified, which cannot be reducedfurther, will need to be communicated to consumers, forinstance through advisory labelling.Figure 1 below illustrates the critical elements that must be considered in assessing allergen risks in a foodmanufacturing environment (numbers refer to sections in the document).Fig. 1: Critical elements in allergen risk managementp // 7
2.2 People2.2.1 TrainingAll involved in the commercialisation, production anddistribution of foods should understand the implicationsof the presence of food allergens and the need tomanage the ensuing risk. Thus, individuals (e.g. topmanagement, marketing, internal auditors, productdevelopers, design engineers, plant personneland contractors, employees handling consumercomplaints) should receive training specific to their jobresponsibilities in this area. They should become awareof measures needed to minimize the risk of allergencross-contact. All appropriate personnel should beencouraged to take immediate action, if any risk ofcontamination is suspected.Allergen training should be provided to all new employeesduring orientation and should be repeated on a regularbasis (annual refresher courses are recommended).Any visitors to site should receive appropriate inductionaccording to site GMP rules.Training and awareness programes shouldinclude as appropriate:General allergen awareness including thenature and possible consequences of theirunintended or undeclared presence in productsand specifics from a consumer perspective.Awareness of allergen presence in rawmaterials and ingredients.Awareness of the hazards and allergenrisks identified at each stage of the food supplychain, including production, storage, transportand/or distribution process and the tation procedures applicable in theindividual’s business.Hygienic design of facilities and equipment inrelation to allergens.Procedures for storage of raw materialsand products, verified and validated cleaningregimes, re-work, label controls and wastemanagement.GMPs covering procedures to minimisecross-contact, including hand washing, use ofprotective clothing including d the site, for example, people changingproduction line or site, movement to thecanteen and of visitors.Equipment movement around the site, forexample, maintenance tools, food trays, etc.Sources of allergen information, e.g. supplierspecifications, supplier audit reports.Human resources procedures to manage therisk to allergic employees who may come intocontact with ingredients.p // 8
2.2.2 Personal HygieneCross-contact of products withallergenic materials may occur dueto poor personal hygiene within amanufacturing facility. The applicationof existing GMP rules should besufficient to minimize the risk ofsuch cross-contamination. However,in relation to allergen controlsthe following aspects should beemphasised:The risk arising from the likelihood ofcross-contact happening with peoplebeing the vector of the contaminationneeds to be assessed. For instance,allergens present as dry products(powders) are much more likelytransferred by people than non-volatileliquids containing allergens.Provision of dedicated work wearfor use in areas handling specificallergens or where a high risk ofcross-contact through clothing exists.Such work wear should be restrictedto working areas (i.e. not in canteenarea, etc.).Employees should not be permittedto bring food or drink into areas whereproducts, ingredients or primarypackaging is exposed.p // 9Contractors and visitors mustcomply with all GMP rules. Copiesof the rules should be provided. Adedicated host should be designatedwhen employing contractors orwelcoming visitors, and the hostshould be responsible for assuringthat they know and comply withGMP rules. Visitors should always beaccompanied by the host.
2.3 Supplier ManagementA food operator at any point in the supply chain canonly perform his own risk assessment effectively ifhe is in possession of correct information about thecomplete allergen status of the raw materials andingredients used. This requires knowledge of eachsupplier’s understanding and application of allergenmanagement. When it comes to allergens and otherrisks, a good relationship between raw material suppliersand manufacturers promotes good product safety.In practice, a food operator will need to:Ascertain that the allergen status is fully describedin raw material, packaging, labelling and specificationsdeclarations. For instance, generic terms such as‘flavouring, spices’ are not appropriate where thesesubstances originate from allergenic sources accordingto European legislation.Assess each supplier and the application ofallergen management practices in their operationsand document that assessment. For instance, this canbe achieved by means of a questionnaire and, whereappropriate, an audit.p // 10Understand the allergen risk analysis from eachsupplier in order to apply the analysis appropriately andconsistently to their products.Ensure that information from suppliers is correctlyrecorded, including complete allergen status i.e.intentionally present allergenic derivatives as well aspotential cross-contact.Lay down procedures on how information receivedfrom the supplier is handled/processed/acted upon.Make sure a change notification process is in placewith the supplier, so that newly identified allergen risksfor ingredients that are already being supplied, areproperly notified and can be acted upon.Where several alternative ingredients can be substitutedin a product, e.g. alternative seasonings and raisingagents with carriers or a particular ingredient mayneed to be purchased from different suppliers, the foodoperator needs to ascertain the impact on the allergenstatus of the resulting product(s).
2.4 Raw Materials Handling2.4.1 Incoming Raw Materials HandlingThe focus at this step should be the clear identification ofincoming raw materials and ingredients and minimisingthe possibility of cross-contact. Thus:Allergenic raw materials, semi-finished products,etc., should be identified upon receipt and, if possible,kept in sealed packaging or separate from each otherand from other foods. Clear labelling reduces the risk ofmix-ups and cross-contact.All deliveries should be checked before unloadingcommences. For all deliveries (including allergenicmaterials) consideration should be given to the need fora special “allergen spillage” procedure, analogous toglass breakage procedures.Where allergenic materials are sampled on delivery,measures should be in place to make sure that thesample and the sampling tools do not create a crosscontact risk, for example, by using colour-coded and/or disposable sampling equipment. Bulk deliverypoints should be locked when not in use to preventunauthorised off-loading prior to the completion ofnecessary checks.2.4.2 Handling of Raw Materials andIntermediate Semi-Finished ProductsThe main risks that arise from raw material storageare cross-contamination of other raw materials andinadvertent selection for a recipe of an allergenicmaterial not present in the product. Thus, the keyprinciples that should be applied are clear identificationand segregation of each allergenic material from othermaterials and each other.As appropriate:Assure/check that allergenic materials aredelivered clearly labelled, and securely packed toprevent accidental misuse, cross-contact or damageprior to receipt.Store allergenic raw materials in clearly identifiedareas, for example, using colour-coded boxes and/ordemarcation of storage areas using painted lines onthe floor.All allergenic materials should be stored in clearlymarked packaging until required.Where allergenic raw materials are de-bagged orde-boxed, they should be placed in dedicated closedand clearly labelled containers. Such containers mustonly be used for storage of other raw materials afterappropriate cleaning using validated procedures.Ingredients, in dry powder form,
FoodDrinkEurope Guidance document on the practical application of the Directive 2003/89/EC on ingredient and allergen labe lling (Version 08/2005). The FDF Dried Foods Industry Guidance on Allergen Control and Risk Management (Version 1.02, August 2008). The Swedish Food Sector Guidelines for management and labelling of food products with reference to Allergy and Intolerance (Version August .
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3. Allergen Risk Assessment, Management and Communication 10 3.1 Allergen Risk Assessment 10 3.2 Allergen Risk Management 14 3.2.1 General Principles 14 3.2.2 Manufacturing 14 People 15 Raw Materials and Supply Chain 16 Manufacturing Premises, Equipment and Processes 18 Cleaning 20 Packaging 21 New Product Development and Reformulation 21
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