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FoodDrinkEurope: Guía sobre la Gestión de Alérgenos en la industria alimentaria


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FoodDrinkEurope: Guía sobre la Gestión de Alérgenos en la industria alimentaria. Enero 2013

FoodDrinkEurope: Guía sobre la Gestión de Alérgenos en la industria alimentaria. Enero 2013

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  • 1. Guidance on Food Allergen Management for Food ManufacturersJanuary 2013
  • 2. Index Foreword .................................................................................... p. 03 Introduction .............................................................................. p. 04 2. Risk Management Processes ........................................................ p. 06 2.1. Overview ............................................................................... p. 06 2.2. People ................................................................................. p. 08 2.3. Supplier Management ............................................................. p. 10 2.4. Raw Materials Handling ........................................................... p. 11 2.5. Equipment and Factory Design ................................................... p. 12 2.6. Production Process and Manufacturing Controls ............................. p. 13 2.7. Consumer Information ............................................................. p. 15 2.8. Product Development and Change .............................................. p. 16 2.9. Documentation and Record-Keeping ........................................... p. 17 3. Cleaning and Cleaning Validation .................................................. p. 18 3.1. General ................................................................................. p. 18 3.2. Cleaning Methods ................................................................... p. 20 4. Analytical Methods and their Application ......................................... p. 22 5. Key Principles of Allergen Risk Management .................................... p. 24 6. Glossary ..................................................................................... p. 26 Annex 1: Background on Food Allergies and Intolerances ........................ p. 32 Annex 2: Allergen Risk Analysis and Management ................................ p. 38 Annex 3: Allergen Labelling ............................................................. p. 56 Annex 4: Allergen Change Over (Cleaning/Flushing) Validation................. p. 64 Annex 5: Allergen Analysis .............................................................. p. 70 Annex 6: Gluten-free Products ......................................................... p. 80p // 2
  • 3. Foreword Jesús Serafín Pérez President Scientific understanding of the risk from food allergens has grown over the last 20 years and continues to develop. Food allergies and intolerances are now well recognised as a food safety issue, which must be managed. Understanding of the risk from allergenic foods remains inconsistent across the industry. Managing the risk to allergic consumers would benefit from an improved consistency of allergen management, methods and practices.The food industry has made significant efforts inimplementing allergen risk management practices.Whilst reducing unintended exposure of allergic Allergenic foods are harmless to theconsumers to allergens, this has also led to the spread of majority of consumers.advisory labelling. This can reduce the choices availableto allergic people, resulting in frustration and risk- Consumers intolerant or allergic totaking behaviour, which negates its purpose. Advisory different foodstuffs can react to a widelabelling on possible cross-contact with allergens is range of amounts of allergenic foods.justifiable only on the basis of a risk analysis applied toa responsibly managed operation. Approaches for the These amounts can vary considerablyapplication of advisory labelling need to be developed. (from micrograms to grams) depending on the individual’s personalIn order to manage their condition, consumers with food tolerance, their health and their currentallergies and food intolerances must be fully informed medication. A few acutely sensitiveabout the nature and composition of the foods they arebuying. Changes in food labelling legislation have led consumers can react to very low levelsto significant improvements in the labelling of allergenic (low micrograms), albeit mildly.ingredients in foods. However, unintended allergenicconstituents can be present in foods as a result of Although much work has been donemanufacturing and other operations. to determine thresholds / no adverseAllergenic foods possess some unique effect levels and use them in foodcharacteristics as a food safety hazard, safety risk assessment, agreementwhich need to be considered in assessing between stakeholders has not yetand managing the risk: been reached on how to interpret this information in public health terms.p // 3
  • 4. 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 be Additionally, the following documents were consideredused to manage specific foodstuffs causing allergy or in the drafting of this Guidance:certain intolerances in different situations. The focusof this Guidance is the production of prepacked foods FoodDrinkEurope Guidance document on theintended for sale to the general population. However, practical application of the Directive 2003/89/EC onthe general principles also apply to non-prepacked ingredient and allergen labe lling (Version 08/2005).foods. Actions that may be appropriate in each specific The FDF Dried Foods Industry Guidance on Allergensituation need to be determined by each individual food Control and Risk Management (Version 1.02, Augustbusiness. Different sectors of the food industry may 2008).have specific requirements that build on the approachset out herein. The Swedish Food Sector Guidelines for management and labelling of food products withIt is not the intention of this document to describe reference to Allergy and Intolerance (Versionrisk management requirements that deliver food August 2005).products which make a claim that they are intended forallergic consumers. The Federalimentare Guidelines on the Labelling of Allergens (Version 2, 6 November 2009).Special thanks and acknowledgment go to the Food Research results from projects such as: “The Basis,Standards Agency (FSA, UK) for agreeing to the Prevalence and Cost of Food Allergies across Europe”use of its “Guidance on Allergen Management and (EuroPrevall FOOD-CT-2005-514000).Consumer Information” (July 2006) as the basis forthis document. Furthermore, express acknowledgment Recommendations re: analytical testing from theand appreciation must be given to Sylvia Pfaff, Food MoniQA EU Network of Excellence.Information Service Europe (FIS), who oversaw thedrafting of this Guidance from its inception and did much International Life Sciences Institute, ILSI Europein compiling the information referenced in this section. Concise Monograph Series - Food Allergy.p // 4
  • 5. Scope ObjectivesThis Guidance has been drafted for the management -in any food manufacturing environment - of allergenic This document aims to:foods and substances (“allergens”) identified in EUlegislation. provide general guiding principles to all food operators regarding food allergenFood companies have a responsibility to establish a risk management, which can be readilyfood safety management system to comply with legal adapted to different product process andrequirements. Allergen Management should be an production facility designs.integrated part of food safety assurance strategiesand should consider the risk from food allergens provide information about food allergytogether with other food safety risks. It should bebuilt into operational standards for a company’s own and food allergens to indicate theirmanufacturing, for third party manufacturing performed importance as food safety hazards.on 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 // 5
  • 6. Risk Management Processes2.1 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 should This evaluation should be carried out by personnel be seen as an integral part of existing food safety appropriately trained in allergen management. management rather than a completely new system. An effective allergen management system must Documented procedures for the control and prevention consider all operations from sourcing of raw materials of contamination must be in place and visible or through manufacturing and packaging to the finished readily available to all employees in the work area. The product, including new product development. procedures should contain information about:Food businesses should operate in line with Good Product development guidelines in terms of allergens.Manufacturing Practice (GMP) principles. This requires Good hygiene, for example, rules regarding clothing,a commitment to ensuring that products meet food hand-washing and hand contact with, quality and legal requirements, using appropriatemanufacturing operations controls, including effective Cleaning of premises, equipment and safety and quality assurance systems. Adherence Handling of rework materials, for example, theto existing GMP controls will be essential for allergen conditions under which such products may be, for example, avoiding cross-contactby segregation using cleaning, separate utensils, line Waste management, for example, how waste shoulddedication, equipment and storage dedication, etc. be labelled and kept separate from rework.Risk management starts with risk assessment, which, Situations where potential cross-contamination canfor allergens, requires consideration of, at a minimum, occur between raw materials, products, productionthe likelihood that they are present, their physical form lines or equipment, and each employee’s responsibility(powder, liquid, pieces, etc), as well as the amount of any for preventing this.allergen present. Risk management must encompass Production scheduling.every component of the supply chain, from raw materialssupply specifications to the sale of the finished product Labelling of raw materials, semi-finished goods andand including product design and development. finished products.p // 6
  • 7. Changes to any process within a food production will therefore require a re-assessment of the originalfacility, or introduction of a new raw material or risk for all potentially affected products and, if required,product, can affect allergen cross-contact risks for application of new risk management measures. Anyother products manufactured at the same site. Moving new relevant risk identified, which cannot be reducedproduction of a product to another site may also alter further, will need to be communicated to consumers, forthe allergenic risk associated with it. Any such changes instance 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
  • 8. 2.2 People2.2.1 Training General allergen awareness including theAll involved in the commercialisation, production and nature and possible consequences of theirdistribution of foods should understand the implications unintended or undeclared presence in productsof the presence of food allergens and the need to and specifics from a consumer perspective.manage the ensuing risk. Thus, individuals (e.g. topmanagement, marketing, internal auditors, product Awareness of allergen presence in rawdevelopers, design engineers, plant personnel materials and ingredients.and contractors, employees handling consumer Awareness of the hazards and allergencomplaints) should receive training specific to their jobresponsibilities in this area. They should become aware risks identified at each stage of the food supplyof measures needed to minimize the risk of allergen chain, including production, storage, transportcross-contact. All appropriate personnel should be and/or distribution process and the correctiveencouraged to take immediate action, if any risk of measures, the preventive measures andcontamination is suspected. documentation procedures applicable in the individual’s business.Allergen training should be provided to all new employeesduring orientation and should be repeated on a regular Hygienic design of facilities and equipment inbasis (annual refresher courses are recommended). relation to allergens.Any visitors to site should receive appropriate induction Procedures for storage of raw materialsaccording to site GMP rules. and products, verified and validated cleaningTraining and awareness programes should regimes, re-work, label controls and wasteinclude as appropriate: management. GMPs covering procedures to minimise cross-contact, including hand washing, use of protective clothing including laundering. Procedures for people traffic patterns around the site, for example, people changing production line or site, movement to the canteen and of visitors. Equipment movement around the site, for example, maintenance tools, food trays, etc. Sources of allergen information, e.g. supplier specifications, supplier audit reports. Human resources procedures to manage the risk to allergic employees who may come into contact with ingredients.p // 8
  • 9. 2.2.2 Personal HygieneCross-contact of products with Contractors and visitors mustallergenic materials may occur due comply with all GMP rules. Copiesto poor personal hygiene within a of the rules should be provided. Amanufacturing facility. The application dedicated host should be designatedof existing GMP rules should be when employing contractors orsufficient to minimize the risk of welcoming visitors, and the hostsuch cross-contamination. However, should be responsible for assuringin relation to allergen controls that they know and comply withthe following aspects should be GMP rules. Visitors should always beemphasised: accompanied by the host. 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 // 9
  • 10. 2.3 Supplier ManagementA food operator at any point in the supply chain can Understand the allergen risk analysis from eachonly perform his own risk assessment effectively if supplier in order to apply the analysis appropriately andhe is in possession of correct information about the consistently to their products.complete allergen status of the raw materials andingredients used. This requires knowledge of each Ensure that information from suppliers is correctlysupplier’s understanding and application of allergen recorded, including complete allergen status When it comes to allergens and other intentionally present allergenic derivatives as well asrisks, a good relationship between raw material suppliers potential cross-contact.and manufacturers promotes good product safety. Lay down procedures on how information receivedIn practice, a food operator will need to: from the supplier is handled/processed/acted upon. Ascertain that the allergen status is fully described Make sure a change notification process is in placein raw material, packaging, labelling and specifications with the supplier, so that newly identified allergen risksdeclarations. For instance, generic terms such as for ingredients that are already being supplied, are‘flavouring, spices’ are not appropriate where these properly notified and can be acted upon.substances originate from allergenic sources accordingto European legislation. Where several alternative ingredients can be substituted Assess each supplier and the application of in a product, e.g. alternative seasonings and raisingallergen management practices in their operations agents with carriers or a particular ingredient mayand document that assessment. For instance, this can need to be purchased from different suppliers, the foodbe achieved by means of a questionnaire and, where operator needs to ascertain the impact on the allergenappropriate, an audit. status of the resulting product(s).p // 10
  • 11. 2.4 Raw Materials Handling2.4.1 Incoming Raw Materials Handling 2.4.2 Handling of Raw Materials and Intermediate Semi-Finished ProductsThe focus at this step should be the clear identification ofincoming raw materials and ingredients and minimising The main risks that arise from raw material storagethe possibility of cross-contact. Thus: are cross-contamination of other raw materials and inadvertent selection for a recipe of an allergenic Allergenic raw materials, semi-finished products, material not present in the product. Thus, the keyetc., should be identified upon receipt and, if possible, principles that should be applied are clear identificationkept in sealed packaging or separate from each other and segregation of each allergenic material from otherand from other foods. Clear labelling reduces the risk of materials and each other.mix-ups and cross-contact. As appropriate: All deliveries should be checked before unloadingcommences. For all deliveries (including allergenic Assure/check that allergenic materials arematerials) consideration should be given to the need for delivered clearly labelled, and securely packed toa special “allergen spillage” procedure, analogous to prevent accidental misuse, cross-contact or damageglass breakage procedures. prior to receipt. Store allergenic raw materials in clearly identified Where allergenic materials are sampled on delivery, areas, for example, using colour-coded boxes and/ormeasures should be in place to make sure that the demarcation of storage areas using painted lines onsample and the sampling tools do not create a cross- the risk, for example, by using colour-coded and/or disposable sampling equipment. Bulk delivery All allergenic materials should be stored in clearlypoints should be locked when not in use to prevent marked packaging until required.unauthorised off-loading prior to the completion of Where allergenic raw materials are de-bagged ornecessary checks. de-boxed, they should be placed in dedicated closed and clearly labelled containers. Such containers must only be used for storage of other raw materials after appropriate cleaning using validated procedures. Ingredients, in dry powder form, can present a particular danger of cross-contamination during handling. Special care should be taken with these types of ingredients. Ascertain segregation and management of allergenic materials at all stages of the manufacturing process, including picking and transfer. In cases where allergenic materials are stored in non-segregated areas, appropriate means of preventing cross contact should be used, for example utilisation of bottom-level racking. Ensure information on the identity of raw materials is readily accessible and available. Considerations for raw material storage also apply to semi-finished products.p // 11
  • 12. 2.5 Equipment and Factory DesignProduction includes ingredient dispensing, recipe Movement Control:make-up, mixing the raw materials and ingredients, Limit movement between physically separated areasprocessing them and then packaging the finished or dedicated equipment, to avoid allergen cross-product. Critical allergen risks related to equipment contact between these and other operations. Manageand factory design include incorrect equipment the movement of equipment, personnel, vehicles andselection, cross-contact between materials as well as maintenance tools.between products produced on the same line. GoodManufacturing Practices (GMP) form the basis for Cleaning:minimising these risks. Where there is a significant risk of cross-contact from shared equipment then the equipment must be capableSpecific considerations to minimise allergen risks of being cleaned effectively. Appropriate protocols mustinclude: be in place to verify and validate the cleaning regime.Equipment and Layout Design: Air:Avoid the crossover of open production lines Implications of potential airborne contamination(for example, conveyor belts) to prevent cross- should be assessed. Dedicated air handling units withcontamination through spillage. Allow adequate space controlled pressure between areas or dust extractionbetween production lines and around equipment to systems might be required for very dusty productionpermit effective cleaning and inspection thus helping to areas. Accumulations of settled allergenic materialminimise the risk of allergen cross-contact. on flat surfaces (e.g. machine guards, window sills, shelves) should be cleaned up.Dedicated Lines, Areas and Equipment:Where practically possible, areas and equipment Non-Food Material Specifications:should be dedicated to a specific allergen profile within Implications of the use in processing areas of othera production facility. This includes weighing equipment, sources of allergenic materials and foods causingscoops and utensils, containers, etc. These tools and intolerances should be risk-assessed. Some examplesaids should be colour-coded or appropriately labelled, include peanut oil in lubricants, wheat flour in cardboardor a validated cleaning programme should be in place. packaging release agents.p // 12
  • 13. 2.6 Production Process and Manufacturing Controls2.6.1 Recipe Verification 2.6.3 Internal Labelling for Handling and ProductionThe first requirement to avoid allergen risks is toensure the correct materials are used in the recipe. There must be control procedures to ensure properSystems therefore need to be designed to avoid recipe labelling of raw materials, semi-finished goods andmistakes. These systems will depend on the actual products. When finished packing materials are of theproduction facility, and can include not only verification same or similar appearance, (e.g. for different flavourof the recipe at the time of addition of materials, but variants), it is especially important to ensure that thealso software and engineering design features to avoid correct packaging is used. In this context, a checklist touse of the wrong ingredient(s). An example would be be signed by the person responsible is recommended.a system which checks barcodes in the recipe againstthose of the raw materials or ingredients when these are Co-products, misshapes and broken products, which forweighed out for a pre-mix and prevents the operator quality reasons are not acceptable as finished productsfrom continuing if they do not match. Rework represents but could still be consumed by employees or solda special case of an “ingredient” which these systems through factory shops, must be subject to the normalalso need to consider. risk assessment and risk communication controls.2.6.2 Separation 2.6.4 Packaging and Post-Production ControlsThere are a number of ways of separating the production Incorrect packaging and/or labelling is a majorof allergen-containing products from those that do not cause of allergen-related product recalls. Procedurescontain the allergen or contain a different allergen. for checking that the correct labels are applied to products should be implemented and audited These can include separation: regularly, so that accurate information is provided By use of dedicated facilities. to allergic consumers. Checks should be in place By use of designated areas (zones) for between processing and packing to ensure the specific allergens. correct packaging is used, for example, with the use of automated label verification systems. By using physical barriers between the production lines. If packaging materials are stored (even for short periods) By minimising unnecessary movement of in processing areas, there is the potential for cross- materials and personnel. contact with allergenic material. Production planning By scheduling production runs (production should include the order in which different products are planning), i.e. where possible, production manufactured and packaged. Special attention must be paid when the production of bulk volumes takes place at runs should be scheduled such that products one location and the packaging of the finished product without allergenic materials are produced first at another. In such cases, the order of packaging must (after the last full cleaning). be designed to reduce the risk of cross-contact by By separating the air supply, where this is allergens and must include effective cleaning routines. appropriate and practicable. Or Combinations of the above.p // 13
  • 14. It is important that, following recipe changes or the 2.6.5 Rework – Internally Recycled Productintroduction of a new allergen cross-contact risk etc,the old packaging is not only withdrawn from use but is Defined procedures for the handling of rework inphysically destroyed, so that it cannot be used in error. production must be in place. Ideally, the principle shouldIt is also essential to ensure that the product is packed be “identical into identical” i.e. rework should go intoin the correct packaging. If packaging variants are of another batch or run of the same product. Where thissimilar appearance, such as different flavour variants, is not practicable, allergen containing rework shouldadditional controls are recommended, for example, by only be used in product where that specific allergeninstalling an inline scanner. is already present (for example, reworking chocolate that contains hazelnuts or hazelnut fillings into otherThere should be systems to ensure packaging is hazelnut-containing chocolate products). Oils used forremoved at the end of a run, including any packaging cooking allergenic foods (for example, shellfish, fishthat may be within the wrapping machine. This will help and breaded or battered products) should not be usedto avoid packaging mix-ups when the product to be subsequently for cooking products not containing thatpacked is changed. allergen without undergoing a validated filtration step.Finished products containing allergens should be The use of re-work material containing allergens mustsecurely packaged so that they cannot contaminate be properly managed and documented. Storage,other products. It is important to ensure that the correct processing, identification and labelling proceduresouter packaging is used for multi-pack products. must all be the same as those for the original allergens. Responsibility for the management of rework must be clearly defined.p // 14
  • 15. 2.7 Consumer Information2.7.1 Ingredient Labelling 2.7.2 Non-commercial Samples (e.g. for taste sessions, exhibitions)Labelling is a very important risk management and riskcommunication tool. Food information legislation in the Complete allergen information for those allergensEU lists foods known to cause allergic hypersensitivity in identified in EU labelling legislation should be availablea significant proportion of the European population, and to European consumers prior to consumption for non-several foods known to provoke intolerance reactions commercial samples (i.e. products not for resalein sensitive individuals such as sulphites, lactose and presented at taste sessions, sent to customers orgluten. Substances or products causing allergies or presented at exhibitions). Alternatively consumersintolerances, as well as ingredients and processing could be pre-screened and rejected from taking part inaids originating from a substance or product causing consuming such commercial samples should they haveallergies or intolerances are required to be declared for any food allergies or intolerances.pre-packed and for non-pre-packed foods, unless thederivatives are specifically exempted by the legislation.As regards prepacked foods, this information mustbe provided on the package or on a label attachedthereto. For non-prepacked foods, Member Statesmay adopt national measures concerning the meansthrough which the allergen information is to be madeavailable and, where appropriate, their form ofexpression and presentation.Labelling of these ingredients, processing aids,substances or products causing allergies orintolerances is obligatory when they are deliberatelyused in the manufacture or preparation of a food andare still present in the finished product, even if in analtered form.The allergen list and exemptions from labelling aswell as details and recommendations for labelling areoutlined in Annex 3 accompanying this document.p // 15
  • 16. 2.8 Product Development and Change2.8.1 Reformulating Products should be mindful of the following when developing new products:Consumers do not always become aware of product Using an allergenic ingredient in a product; andrecipe change unless some clear indication is given. Thisis particularly so for allergic consumers, who will often Introducing new allergens into new formulations ofremain loyal to a product they trust and is particularly existing products/ brands.important when the allergen profile changes. Therefore,when an existing recipe is changed or one ingredientis substituted for another one containing allergens (or Successful implementation of new productsdifferent allergens), the consumer should be clearly into existing manufacturing facilities willinformed about the change in product composition. Thiscan be done, for example, by using prominent labelling require attention to the following principlesflashes, preferably on the front of the pack, in addition to prior to starting production or running trials:the amended ingredients list. Suitable warnings might Ensure all documentation is updatedbe, for example, “New Recipe” or “Now Contains”. accurately and completely.It may also be possible to use other methods such Inform relevant personnel in good timeas websites and patient group updates, to inform when new allergenic ingredients are to beconsumers of recipe changes. In addition, food used, so that they can perform an ingredientoperators and retailers are recommended to provideupdated information to consumer support/allergic assessment and as required design a plan topatient organisations as they have systems in place manage them.for informing their members about changes and this Ensure conduct of factory trials of allergen-approach helps to target the information at those whoare most at risk. containing products includes measures to avoid allergen cross-contact with existing2.8.2 New Product Development products.The starting point for all food production is ensuring Ensure information on the presence, orthat complete product specifications are available. potential presence, of allergens is madeIn product development, the ingredients and available to those involved in factory trialsmanufacturing procedures should be looked at from and in taste allergy perspective. The people responsible fordevelopment of products and recipes must have sound Ensure information is clearly conveyedknowledge of the risks to people with food allergies with products presented for wider test andand other food intolerance. By definition, most food marketing purposes.allergens are common and valuable components of thediet and it is neither practicable nor even desirable toexclude them from new products. However, in order notto add complexity to existing allergen risk managementpractices, new product development technologistsp // 16
  • 17. 2.9 Documentation and Record-KeepingEfficient and accurate record keeping is critical to the A record of the risk management programme should beapplication of allergen management within a food safety retained with the risk assessment to demonstrate dueprogramme. A simple record-keeping system can be diligence. This may be shared, as appropriate, witheffective and easily communicated to employees. It enforcement agencies and customers to demonstrateshould be integrated into existing operations using how risks have been managed and reduced. This shouldexisting paperwork, such as delivery invoices and include details of how the programme is validated,checklists to record allergen status. and ongoing verification. Internal compliance with instructions and procedures for control of allergen risks should be verified regularly by trained internal auditors.p // 17
  • 18. Cleaning and Cleaning Validation3.1 GeneralEffective cleaning is one of the most important aspects of any allergen problems and any relevant industrymanagement strategy. A “visually and physically clean” Standard is not just guidance, where this has beena casual visual inspection of the production line or area, it also requires that developed, should be followed.all of the trouble spots are identified and inspected (key inspection points Adequate procedures should be inshould be highlighted on cleaning schedules). place for cleaning both production and packaging machinery.Cleaning considerations should be the whole production line may be Where adequate cleaning cannotbuilt into the design of equipment. visually assessed and complies be assured (e.g. because ofFor instance, dismantling should with the visibly clean Standard (no inaccessibility), the residual riskbe made easy so that hidden product residue visible). from allergen cross-contact shouldareas of the equipment can be be assessed and advisory labellingadequately accessed and cleaned Documented and validated used, if deemed failure to clean properly can cleaning procedures using properlead to a build-up of raw material cleaning equipment are essential The actual cleaning procedureor product residue inside the to ensure that effective cleaning is must not contaminate other areasequipment. Avoiding the crossover performed. Adequate time must be (for example, by use of compressedof production lines and allowing allocated for cleaning.adequate space for effective air), or an area which has alreadycleaning will also help minimise the Cleaning practices that are been cleaned (for example,risk of allergen cross-contact. satisfactory for microbiological clean dry mix areas from the top safety may not be adequate for down). Any spillage that occursLine cleaning must be evaluated removing some allergens and during production, storage andfor its ability to control the hazard; their validity for such a purpose transportation should be cleanedi.e. issues with heterogeneously should be assessed. Equipment up immediately to ensure that theredistributed common allergen may need to be dismantled and is no subsequent allergen cross-traces due to cross-contact and manually cleaned to ensure contact. Where known allergeneffectiveness of (controlled) wet or hard to clean areas are free from cross-contact has occurred, thedry cleaning need to be assessed. allergen residues. Particular food contaminated material should beLine cleaning of heterogeneously materials (for example, powders, labelled and physically moveddistributed allergenic material will seeds, pastes and particulates) away from the non-contaminatedbe considered as effective only if may present significant cleaning ingredients and work-in-progress.p // 18
  • 19. Consideration should be given to maintenance activities,such as the use of dedicated tools or adequate cleaningprocedures where tools are not dedicated. Whereadherence to a cleaning regime is part of a separationsystem, it should be validated as “fit for purpose” andcompliance should be monitored.Investment in developing and following appropriatecleaning regimes will help to minimise food allergencross-contact and can reduce the likelihood of needingcostly product recalls. Key Cleaning Principles for Allergen Control: Ensure that cleaning equipment itself is de- dicated (if possible) and cleaned after use to minimise the risk that it may carry and transfer allergen traces. Establish appropriate cleaning regimes. Validate cleaning regimes. Verify that cleaning is being done effectively. Keep records of cleaning.p // 19
  • 20. 3.2 Cleaning Methods3.2.1 Wet Cleaning material addition points, internal hoppers and packing machinery. It is unlikely to be sufficient to flush only theWet cleaning systems can be very effective and are primary process (main mixer, etc.).the best cleaning option, where practicable and usablewithout introducing microbial risk. They are particularly Consideration should be given to the quantity andeffective where allergens are in a form that may be nature of the flushing material. Flushing agentsdifficult to remove using dry cleaning only. The cleaning should be inert non-allergenic materials such as salt.stage and cleaning chemicals must be capable of Where the chosen flushing agent is not a significantremoving all contaminants and the rinsing stage must ingredient in the next production batch, an additionalbe sufficient to flush the system. clean may be appropriate.In dry food manufacturing environments, a separate Used flushing materials should be identified, handledrisk assessment should be undertaken to ensure that and stored using the same controls as for the originalno microbiological hazards are introduced as a result of allergen which the flush now potentially contains.any wet cleaning procedures. Subject to an individual company’s risk assessment, it may be appropriate for used flush material to be used3.2.2 Dry Cleaning as an ingredient in a production batch containing a similar allergen profile (e.g. salt used for flushing afterWhere dry cleaning is undertaken, the use of brushes, the production of an egg-containing batter could bedustpans etc. is acceptable, but suitably filtered/ used as an ingredient for subsequent production ofprotected vacuum systems are often preferred. The the same or a similar egg batter). Otherwise, the flushuse of compressed air is strongly discouraged, as the material should be carefully disposed of in a mannerairstream could re-contaminate adjacent equipment or which will not lead to cross-contact.carry allergens into clean areas. Cleaning equipmentshould be well maintained. The most effective and cost efficient methods for prevention of allergen cross-contact may be basedIt is essential that cleaning equipment is itself cleaned on a combination approach, for example scheduling,to prevent the transfer of allergens. Dedicated cleaning cleaning and flushing. The nature and extent of anyequipment which is identified by colour can be used to cleaning programme will be determined by the riskminimize cross-contamination. assessment.3.2.3 Flushing 3.2.4 Validation and Verification of CleaningThe use of flushing materials as a mechanism for In addition to routine cleaning verification (the processremoving and/or reducing levels of allergenic materials line is inspected and signed back into normal usecan be beneficial and can be more effective when used after cleaning to confirm that all detailed measures,in combination with other cleaning methods. Flushes cleans, flushes, etc. Have been completed), it isshould pass through all parts of the plant with which necessary to regularly demonstrate that allergenthe allergen may have been in contact, including raw protocols remain effective.p // 20
  • 21. It is recommended that the validation be carried by A validation study requires the physical validation ofa multi-skilled team. In addition to production staff, the cleaning (post cleaning and/or pre-operationalthe team could include (as appropriate) engineers, inspection process) combined with quantitativequality specialists, hygiene specialists, and people analytical evidence by using validated analyticalwith knowledge of allergens. It is important to include methods. When no test for the analytical validation ispeople with detailed knowledge of the process, the available, allergen line validations should follow theequipment and the relevant cleaning procedure. It is physical validation protocol only and then complyalso important that the related cleaning procedures are with the visibly clean Standard (no product residue) ordeveloped and thoroughly documented in advance of test for a marker allergen (a labelled allergen with theany validation activity. highest percentage by formula). Documented validation should be considered part of the The first step of a good ‘cleaning validation’ plants’ HACCP programme, and be done in addition, if is to define a ‘worst case’. For example: changes in formula, the process, equipment or cleaning procedures are identified to present an unavoidable Which allergenic derivative is the most likelihood of cross-contamination. complicated/challenging to clean (e.g. sticky materials, particulates). Which one is used in a higher quantity? Which one is used in the highest proportion in a recipe?p // 21
  • 22. Analytical Methods and their ApplicationAllergen management depends on a number of factors outlined in this Guidance document. Analysiscan help and support understanding of allergen management capability and control but should never beregarded as the sole tool sufficient for allergen management.Analytical testing is inappropriate for quality control ATP (adenosine tri-phosphate) and protein assays arepurposes but supports upstream quality assurance, also on site assays but not specific for allergens. Thesevalidating cross-contamination control capability. detect general contamination with biological material /proteins which are not necessarily the allergens ofThe typical applications of analytical testing are: concern, but can indicate level of cleaning capability. Provision of quantitative data for the purposes of risk Analytical results can be misleading unless criticalassessment; considerations are built in along with competent technical advice. These considerations include: Confirmation of raw materials composition; Validation of allergen control measures such ascleaning practices, scheduling and segregation barriers; Choice of appropriate method (sensitivity, Monitoring suppliers’ control capability; and selectivity, specificity and reproducibility). Confirming the status of any allergen claims. Confirmation that an analytical test has been validated for each of the food matricesAllergen analysis is divided into different methodsfor different purposes. The most commonly used are to be tested.lateral flow devices or dipsticks and ELISA (Enzyme Risk-based sampling programme islinked immuno-sorbent assays), which are protein- relevant to the site, production equipmentbased. Some mass spectrometry methods are alsoemerging. PCR (polymerase chain reaction) assays, and process, and product.since they are typically indirect tests (detecting non-allergenic DNA but not protein) are only useful whereprotein detection assays are not available (e.g. celery).Lateral flow devices can be used by trained factoryworkers on site while ELISA, mass spectrometry andPCR have to be performed in specially equippedaccredited laboratories.p // 22
  • 23. Analytical results are very useful when the effectivenessof cleaning procedures (cleaning validation) needsto be assessed. Here, quantitative values give aninsight whether the procedure is appropriate to removeallergens from the production line. On site swabbingtest and dipstick tests can indicate that the testedpart of the production line remains free from allergens(to its limit of detection). However, a single test resultdoes not provide sufficient information about theallergen presence/absence. A single test as part of aholistic allergen management review to verify absenceof allergens is very good supporting evidence of thesuccess of the risk management control measure.I. More details in Annex 5 – Methods for allergen detection.p // 23
  • 24. Key Principles of Allergen Risk ManagementIn summary, the allergen status of all raw materials (including intentionally present flavourings, additives,carriers, rework and processing aids and assessment of probable cross-contact), should be known. Foodoperators must be able to demonstrate their responsibilities as follows:• Policy and Guidance • Supply Management Manage potential risks from allergenic Implement a specific supplier foods. management review related to allergen risk. Operate in line with Good Manufacturing Practice (GMP). Check the allergen status of all raw materials with suppliers and review Integrate allergen risk management in regularly. existing food safety management. Ask suppliers to notify the allergen Document specific allergen risk status (intentional and cross-contact) of management procedures. the materials they supply and any changes to the status.• People Identify allergen management-related training needs of all personnel. Deliver training on allergen risk to personnel according to the needs of their role. Implement rules for personal hygiene.p // 24
  • 25. • Manufacturing • Communication Handle incoming raw materials and Ensure that recipes, manufacturing, ingredients according to the Allergen packaging and consumer information Management Plan. is produced with a high awareness of allergen risks. Clearly identify allergenic raw materials and segregate as appropriate. Approaches for the application of advisory labelling need to be developed. Ensure that stored raw materials and ingredients with allergens will not pose a risk of cross-contact to non-allergenic goods. Ensure the handling of allergenic ingredients does not create a risk of cross- contact with other raw materials. Check implications of any change of raw material supplier. If applicable, understand the rationale for suppliers using advisory labelling. Implement validated cleaning procedures.p // 25
  • 26. Glossary of TermsAllergen of the “allergen status” of materials whether the correct packaging is necessary to allow assessment has been used for the productAllergens are antigens which cause of any risk they may present, and scheduled to be manufactured, andallergy. Most allergens reacting subsequent effective allergen risk stop the line if incorrect packagingwith IgE or IgG antibodies are management. has been used in error.proteins, often with carbohydrateside chains, a foreign substance Allergenic constituents Coeliac diseaseor protein (antigen) that stimulates or allergenic derivatives A disease in which the mucosa ofan allergic reaction. Products, by-products or their the small intestine is damaged byAllergy components which have the exposure to gluten (also known as potential to provoke an allergic gluten sensitive enteropathy).Allergy is a hypersensitivity reaction in sensitised individuals.reaction initiated by immunological Cross contactmechanisms. Food allergy is an IgE- Anaphylaxis In the context of food allergens,mediated hypersensitivity reaction,which can lead to anaphylaxis. A generalised inflammatory “cross-contact” occurs when aA state in which objectively immunologic reaction to a foreign residue or other trace amount ofreproducible symptoms or signs protein in a sensitised individual, an allergenic food is unintentionallycan be initiated by immunologic which may be severe enough transferred into another food,mechanisms after exposure to a to be life-threatening. A severe, despite good manufacturingdefined stimulus at a dose tolerated life-threatening, generalized or practices (GMP).by normal subjects. systemic hypersensitivity reaction. Cross-contaminationAllergen status Antibody An alternative expression forIn this Guidance, the term “allergen A protein molecule (immuno- cross-contact.status” refers to the presence, globulin) produced and secretedor not, of any allergenic foods or by B lymphocytes in response to Enzymetheir derivatives in a raw material, an antigen, which is capable of Proteins that catalyse the reactionsby-products, rework or processed binding to that specific antigen. of metabolism, speeding them upfood product. This status includes without themselves being usedallergen presence whether Automated label verification up in the reaction. Each enzymeintentionally present, or potentially systems is specific for a given substratepresent as a result of unintended Production systems, usually in- or reaction.cross-contact. Accurate knowledge line, which can automatically verifyp // 26
  • 27. Food additive carrying out any of the activities lactose intolerance is caused related to any stage of production, by a deficiency of the digestiveAny substance not normally processing and distribution of food. enzyme, lactase.consumed as a food in itselfand not normally used as a Food Business Operator (FBO) Food safety hazard analysischaracteristic ingredient of food,whether or not it has nutritive value, The natural or legal persons A food safety hazard analysis isthe intentional addition of which to responsible for ensuring that the done in order to determine whichfood for a technological purpose requirements of food law are met potential hazards need to bein the manufacture, processing, within the food business under controlled, how much control ispreparation, treatment, packaging, their control. needed, and which combination oftransport or storage of such food control measures should be used inresults, or may be reasonably Food Hygiene order to make sure that food is safe.expected to result, in it or its by- The measures and conditionsproducts becoming directly or Food Safety Management necessary to control hazardsindirectly a component of such System (FSMS) and to ensure fitness for humanfoods. consumption of a foodstuff taking A network of interrelated elements into account its intended use. that combine to ensure that food doesFood allergy not cause adverse human healthAn IgE-mediated hypersensitivity effects. These elements include Food informationreaction. programmes, plans, policies, Information concerning a food procedures, practices, processes,Food allergy occurs when the and made available to the final goals, objectives, methods, controls,immune system becomes sensitised consumer by means of a label, roles, responsibilities, relationships,to specific food antigens, usually other accompanying material, documents, records and resources.proteins. Subsequent exposure to or any other means including A FSMS is often one part of a largerthe specific allergenic protein when modern technology tools or verbal management system.ingested can produce adverse communication.reactions in the sensitised person,which can include potentially fatal Food intoleranceanaphylaxis. A hypersensitive reaction which is non-allergic, where immunologicalFood business mechanisms have not beenAny undertaking, whether for profit proven or are not responsibleor not and whether public or private, for the reaction. For example,p // 27
  • 28. Good Manufacturing Practice Hazard is capable of binding to that(GMP) specific antigen (also known as an A biological, chemical or physical antibody).A production and testing practice agent in, or condition of, food withthat helps to ensure a quality the potential to cause an adverse Inflammationproduct. Basic preventive health effect.guidelines for plant and facility General term for the reactionoperations. Guidelines aimed at Hypersensitivity of tissues to injury, infection orfood processors aim to include all a localised immune (allergic) A state in which objectivelyHACCP methods and procedures response; characterised by the reproducible symptoms or signsand typically address (1) plant infiltration of inflammatory cells and can be initiated by exposuredesign and construction material, clinically by heat, redness, swelling to a defined stimulus at a dose(2) water supply, (3) plumbing and and pain. tolerated by normal subjects.toilet facilities, (4) equipment and Hypersensitivity causes objectivelyutensils, (4) raw food handling Ingredient specifications reproducible symptoms or signs,and testing practices, (5) personal initiated by exposure to a defined Technical document used to definehygiene, (6) pest control, and (7) stimulus that is tolerated by normal the critical parameters of rawwaste disposal. subjects. Food allergy is an IgE- materials, processes and finished mediated hypersensitivity reaction products which are necessaryHACCP (Hazard Analysis to allergenic foods and their to manufacture the quality,Critical Control Point) derivatives in sensitised individuals. composition and characteristics intended, including allergenHACCP is a methodology and a IgA, IgD, IgE, IgG, IgMIgE system. It is usedto identify, prevent, and control Classes of safety hazards. HACCP Ingredient Immunoglobulin E is a type ofmanagement systems use the antibody which may cause an Any substance or product, includingfollowing methodology: allergic reactions found in the flavourings, food additives and immune system. We produce food enzymes, and any constituent1. Conduct a hazard analysis. IgE molecules to fight infections of a compound ingredient, used in2. Identify critical control points caused by parasites, like worms; the manufacture or preparation of a(CCPs). or those that cause malaria. We food and still present in the finished3. Establish critical limits for each do not understand why, but the product, even if in an altered form;critical control point. immune system of some people residues shall not be considered as4. Develop procedures to monitor mistakenly produces IgE to ‘ingredients’.critical control points. harmless things like pollen or dust5. Design corrective actions to mites, giving rise to hay fever and Labelhandle critical limit violations. asthma, and to some foods, giving Any tag, brand, mark, pictorial or6. Create a food safety record rise to food allergies. other descriptive matter, written,keeping system. printed, stencilled, marked,7. Validate and verify your safety Immunoglobulin embossed or impressed on, orsystem. attached to the packaging orHACCP was developed by the A protein molecule produced container of food.Codex Alimentarius Commission. and secreted by B lymphocytes in response to an antigen, whichp // 28
  • 29. Labelling Management reviews are also used Packaging to identify and assess opportunitiesAny words, particulars, trademarks, The placing of one or more to change an organisation’s qualitybrand name, pictorial matter foodstuffs in primary wrapping, in policy and quality objectives, toor symbol relating to a food a secondary container, and any address resource needs, and toand placed on any packaging, subsequent containers. look for opportunities to improve itsdocument, notice, label, ring or products.collar accompanying or referring to Pre-packed foodsuch food. Manufacturing process Any single item for presentation as such to the final consumer andLactose intolerance Manufacturing processes are the to mass caterers, consisting of a steps through which raw materialsA state in which an individual is food and the packaging into which are transformed into a final product.unable to digest significant amounts it was put before being offeredof lactose, the predominant sugar for sale, whether such packagingin cow’s milk. This results from a Microbiological safety encloses the food completely ordeficiency of the enzyme lactase, only partially, but in any event A ‘microbiological criterion’normally produced by the mucosal in such a way that the contents means a criterion defining thecells of the small intestine. cannot be altered without opening acceptability of a product, a batch or changing the packaging; ‘pre- of foodstuffs or a process, basedManagement packed food’ does not cover foods on the absence, presence or packed on the sales premises atAll the activities that are used to number of micro-organisms, and/ the consumer’s request or pre-coordinate, direct, and control an or on the quantity of their toxins/ packed for direct sale.organization. The term management metabolites, per unit(s) of mass,does not refer to people. It refers to volume, area or batch (Regulation Prerequisite Programme (PRP)activities. (See top management (EC) No. 2073/2005).below for reference to people). The conditions that must be Operating procedure established throughout the foodManagement Review chain and the activities and A document which describes the practices that must be performedThe purpose of a management regularly recurring operations in order to establish and maintainreview is to evaluate the overall relevant to the quality of the a hygienic environment. PRPsperformance of an organisation’s investigation. The purpose of an must be suitable and be capablefood safety management system operating procedure is to carry out of producing safe end productsand to identify improvement the operations correctly and always and providing food that is safe foropportunities. These reviews are in the same manner. An operating human consumption. PRPs supportcarried out by the organisation’s top procedure should be available at HACCP plans.managers and are done on a regular the place where the work is done.basis. The overall purpose of a Processingmanagement review is to evaluate Operational standards Any action that substantiallythe suitability, adequacy, and Qualitative or quantitative technical alters the initial product, includingeffectiveness of an organisation’s requirements which must be met heating, smoking, curing, maturing,quality management system, and to to achieve intended targets and drying, marinating, extraction,look for improvement opportunities. characteristics of a process, part- extrusion or a combination of those product or finished product. processes.p // 29
  • 30. Processing aid Risk Senior / Top managementAny substance which (i) is not A function of the probability of an A person or a group of peopleconsumed as a food by itself; adverse health effect occurring at the highest level within an(ii) is intentionally used in the upon exposure to an identified organisation. It refers to the peopleprocessing of raw materials, foods hazard. who coordinate, direct and controlor their ingredients, to fulfil a certain organisations.technological purpose during Risk analysistreatment or processing; and (iii) A process consisting of three Small and Medium-sizedmay result in the unintentional but interconnected components: risk Enterprise (SME)technically unavoidable presence assessment, risk management and The category of micro, small andin the final product of residues of risk communication. medium-sized enterprises (SMEs)the substance or its derivatives is made up of enterprises whichprovided they do not present any Risk assessment employ fewer than 250 personshealth risk and do not have any A scientifically based process and which have an annual turnovertechnological effect on the final consisting of four steps (i) not exceeding EUR 50 million, and/product. hazard identification (ii) hazard or an annual balance sheet total not characterisation, exposure exceeding EUR 43 million.Raw material assessment (iii) and (iv) riskMaterial before being processed or characterisation. Validationmanufactured into final form. A process that is used to ensure Risk management that food safety control measuresRetail The process, distinct from risk are capable of being effective. assessment, of weighing policy The validation process usesThe handling and/or processing alternatives in consultation with evidence to determine whetherof food and its storage at the interested parties, considering risk control measures are capable ofpoint of sale or delivery to the final assessment and other legitimate controlling or managing identifiedconsumer, and includes distribution factors, and, if need be, selecting food safety hazards and ensuringterminals, catering operations, appropriate prevention and control that end-products are safe.factory canteens, institutional, restaurants and other Verificationsimilar food service operations, Risk communication Act or process of establishingshops, supermarket distribution The interactive exchange of (confirming) the accuracy orcentres and wholesale outlets. information and opinions throughout existence of something; in the risk analysis process as regards the quality field, verification isRework hazards and risks, risk-related a systematic, objective, andTaking by-products from a specific documented process of confirming factors and risk perceptions,food manufacturing process and that a product or service conforms among risk assessors, riskeither re-processing to ensure a to various requirements (customer, managers, consumers, feed andproduct meets specification, or regulatory, etc.). A process that food businesses, the academicrecycling by-products back into the uses objective evidence to confirm community and other interestedprocess for efficiency purposes. that specified requirements have parties, including the explanation of risk assessment findings and the been met. basis of risk management decisions.p // 30
  • 31. p // 31
  • 32. Annex 1 Background on Food Allergies and Intolerancesp // 32
  • 33. Introduction What is a food allergy?Food allergies affect around 2 to 4% of the population (1, Food allergy refers to an inappropriate immune response2) in Europe and an estimated 5-8% of children. Allergic to a food constituent (almost always a protein), causingreactions to foods also account for a high proportion of the food to provoke an allergic reaction when it is eatenadmissions to hospitals for acute allergic reactions (3). again. Foods can produce many different types ofThis means that in the 500 million population of the 27 allergic responses, but from a public health and foodEU Member States, an estimated 10-20 million people safety perspective, those with the greatest impactsuffer from a food allergies. However, the number who are those in which the immune system produces IgEbelieve they have a food allergy is considerably higher antibodies to proteins in the food and those reactions areat around 20% of the population (4). Many children the primary concern of this guidance. Care needs to beoutgrow their allergies, such as those to milk and eggs taken to differentiate food allergy from food intolerance,by the age of 5-7 years. Other allergies, such as to fish such as lactose intolerance, which does not involve theand peanuts, tend to persist. For practical purposes, no immune system (see below).cure exists for food allergy and allergic consumers mustavoid foods which contain the ingredient(s) to whichthey are allergic.Classification of Food Allergy and Food Intolerance by European Academy of Allergy and Clinical Immunology (EAACI), 2004.p // 33
  • 34. Allergic reactions to food can vary from very slight tosevere and occasionally fatal, depending on the dose, These symptoms can include onethe individual and other factors. Food allergy affects or more of the following.a greater proportion of children than adults (5) andreactivity to some allergenic foods, such as milk and Skin problems (hives, itching,egg, tends to be largely outgrown, while allergy to dermatitis, eczema, conjunctivitis,others, such as peanuts, generally persists. swelling of the lips, mouth).During an IgE-mediated reaction to a food, rapid release Respiratory problems (rhinitis,of chemicals in the body (e.g. histamine) occurs, asthma, breathing difficulties,resulting in symptoms sometimes within minutes but swelling of the throat).occasionally up to 2 or more hours after ingestion of theoffending food. Gastrointestinal problems (nausea, stomach pain, vomiting, diarrhoea). In rare cases, a severe systemic reaction may occur, leading to a sudden drop in blood pressure, severe constriction of the airways, a generalised shock reaction and multiple organ failure. This is known as anaphylactic shock and can lead to death within minutes if not treated with adrenaline. Only a small number of people with food allergies are at risk of such serious reactions, but there are nevertheless many documented cases of death resulting from accidental ingestion of an offending food. Oral allergy syndrome (OAS) is a form of food allergy in which people become allergic through inhaling pollen proteins and then react to similar proteins in foods. Generally, the symptoms can only be felt by the allergic person (itching) severe reactions are extremely rare. Typically OAS occurs with fruits and vegetables. Whether a person develops a food allergy (or indeed any allergy) depends on complex interactions between individual susceptibility and factors related to exposure and the circumstances in which it occurs (e.g. concurrent viral infection, etc). Children born to allergic parents are more likely to become allergic themselves. Most food allergies begin in childhood, but onset can also take place later in life.  p // 34
  • 35. How Much is Too Much?The range of minimum doses required to provoke a doses in the allergic population for some allergensreaction in allergic people (thresholds) spans a very (6), making it possible to assess allergen riskswide range, from micrograms to grams. Recent work quantitatively (7).has helped to characterise the distribution of these Distribution of minimun eliciting doses (thresholds) in peanut-allergic patients from allergy clinics (from reference 6). The distribution shows that 10% of the tested population would react to about 17mg of peanut.p // 35
  • 36. Other Adverse Reactions Food Processing andto Foods Involving the AllergenicityImmune System Because allergic reactions start with the recognitionCoeliac disease manifests itself as an immunologically of the allergen (protein), any process that modifies themediated, non-IgE reaction to gliadin, a prolamin (gluten structure of a protein will have the potential to affectprotein) found in wheat, and similar proteins found in allergenicity. Food processing induces several physical,the crops of the tribe Tritiaceae (which includes other chemical and biochemical changes that are known tocultivars such as barley and rye). It is an autoimmune potentially impact the allergenic potential of proteins.disorder of the small intestine that occurs in genetically Certain methods of food processing may enhance,predisposed people of all ages from middle infancy reduce, or eliminate the allergenic potential of a food (9).onward. Symptoms include chronic diarrhoea, failureto thrive (in children), and fatigue, but these may be Removal of the protein fraction of the food canabsent, and symptoms in other organ systems have reduce exposure to allergens sufficiently to preventbeen described. Over the longer-term, osteoporosis allergic reactions (e.g. highly refined seed oils). Thisand other severe health effects have been reported. is recognised by the exemptions granted in the labelling legislation. However, there are no general rules regarding how different allergenic foods respond to physical (i.e., thermal, mechanical), chemical, orWhat is food Intolerance? biochemical processing methods. Consequently, unless sound evidence exists that a specific processingFood intolerance refers to adverse reactions to foods, method reduces allergenicity, it should be assumed thatwhich do not involve the immune system and are the allergenic potential of a processed food is identicalnot usually the result of inherent toxicity, but of some to that of the food in its unprocessed form.characteristic of the food (pharmacological activity),the affected individual (enzyme deficiency) or wherethe cause is unknown. Although not usually immediatelylife-threatening, such reactions can make the sufferer To find out more:feel extremely unwell and can have a major impact on Jackson WF (2003) food allergy. ILSI Conciseworking and social life. Monograph Series. ILSI Press, Brussels.Because of the nature of food intolerance, symptoms www.foodallergens.infocannot be precisely defined. They may occur veryrapidly and mimic an allergic reaction (e.g. biogenic a website developed by the Integratedamines), but can also develop over many hours until the Project Europrevall for the food industryoffending substance has been removed (e.g. lactoseintolerance). Often the symptoms are vague and not  always easily diagnosed.People with food intolerance have to adapt their foodconsumption to their individual intolerance. It is oftennot necessary to avoid the food completely, e.g. in thecase of lactose intolerance (8).p // 36
  • 37. References 6. Taylor, S.L., Crevel, R.W.R., Sheffield, D., Kabourek,1. Kanny, G; Moneret-Vautrin, DA; Flabbee, J; J., Baumert, J.(2009) Threshold Dose for Peanut: RiskBeaudouin, E; Morisset, M; Thevenin, F (2001). Characterization Based Upon Published Results fromPopulation study of food allergy in France. J Allergy Clin Challenges of Peanut-Allergic Individuals,Food andImmunol. 2001 Jul; 108(1): 133-140. Chemical Toxicology 47, 1198-1204.2. Zuberbier T, Edenharter G, Worm M, Ehlers I, 7. Kruizinga AG, Briggs D, Crevel RW, Knulst AC, vanReimann S, Hantke T, Roehr CC, Bergmann KE, den Bosch LM, Houben GF (2008) Probabilistic riskNiggemann B. (2004) Prevalence of adverse reactions assessment model for allergens in food: sensitivityto food in Germany - a population study. Allergy. 59: analysis of the minimum eliciting dose and food338-345. consumption. Food Chem Toxicol. 46:1437-1443. Epub 2007 Oct 1.3. Worm M, Timmermans F, Moneret-Vautrin A, MuraroA, Malmheden Yman II, Lövik M, Hattersley S, Crevel R. 8. EFSA Panel on Dietetic Products, Nutrition andTowards a European registryof severe allergic reactions: Allergies (NDA); Scientific Opinion on lactose thresholdscurrent status of national registries and future needs. in lactose intolerance and galactosaemia. EFSA JournalAllergy 2010; DOI: 10.1111/j.1398-9995.2010.02332.x. 2010;8(9):1777. [29 pp.]. doi:10.2903/j.efsa.2010.1777.4. Rona RJ, Keil T, Summers C, Gislason D, Zuidmeer 9. Thomas K, Herouet-Guicheney C, Ladics G, BannonL Sodergren E,. Sigurdardottir ST, Lindner T, Goldhahn G, Cockburn A, Crevel R, Fitzpatrick J, Mills M, Privalle L,K, Dahlstrom J, McBride D, Madsen C (2007) The Vieths S (2007) Evaluating the effect of food processingprevalence of food allergy: A meta-analysis. J Allergy on the potential human allergenicity of novel proteins:Clin Immunol 120:638-646. International workshop report. Food and Chemical Toxicology 45 (2007) 1116–1122.5. Sampson HA (2005) Food allergy--accuratelyidentifying clinical reactivity. Allergy 60 Suppl 79:19-24.p // 37
  • 38. Annex 2 Allergen Risk Analysis and Managementp // 38
  • 39. Allergen Risk Analysis and ManagementEffective risk management of food allergens requires appropriately trained experts, such as members ofcareful consideration of allergen presence, both HACCP teams, as an integral part of the manufacturer’sintentional from the recipe, and unintended through quality and food safety system.cross-contamination across all stages of food productionfrom farm to fork. The allergenic foodstuffs and their derivatives which should be considered are those which have beenAllergen HACCP risk assessments will help to identify identified as of public health importance and requirewhere allergen hazards occur and whether the mandatory labelling, as outlined in EU legislation. Theexisting systems can manage the potential risk under same approach could be utilised generically for othernormal operating conditions and good manufacturing allergenic foodstuffs.practice. Such risk analysis should be undertaken by1. Characterisation of the Risk from AllergensCharacterisation of potential risk from the presence Where practical and feasible, manufacturing processesof allergens in the finished manufactured product should be modified to minimise the probability and extentis a fundamental activity within any food operation of cross-contamination. Approaches for application ofHACCP and should be done for each individual food advisory labelling need to be developed.handling site. These stages of characterisation require informationThere are several recommended steps for allergen risk as to allergen presence in the recipe and in potentialcharacterisation to ensure the necessary information is cross-contamination scenarios for all the allergens ofavailable, and the necessary assessment considerations concern to a significant level of detail. They also requirehave been covered. Completion of these stages will allow a thorough understanding of the likelihood of cross-a food operator to determine whether allergen labelling contamination, and demand evidence of the capabilityis required for the finished product, identify the specific of manufacturing controls to remove/avoid cross-allergen-derived foodstuffs which need to be declared, contaminating allergen presence.and whether, despite good manufacturing practicesand allergen risk management controls, any additional The assessment described can also be used foradvisory warning might be required to provide further internal audits of allergen controls as a formal validationrisk communication to allergic consumers. form to support site specific HACCP programmes, for evaluations of current manufacturing practices andAdvisory labelling for the unintentional presence of changes to them, for risk assessments when newallergens should only be used when following a thorough allergen containing products are being introduced,risk assessment, there is a significant probability of and for evaluation of the impact of changes to existingallergen cross-contamination occurring at a level which products (e.g. changes in the allergen list) and changesposes an unacceptable risk to allergic consumers. to processes.p // 39
  • 40. 2. Stages of an Allergen HACCP Risk Analysis2.1. Identify all allergens 2.1.2. Identify potential 2.2.1. List all the concernedpresent on site opportunities for cross-contact products / processes / lines and within suppliers’ operations their respective allergen profiles,Aim: To identify allergen hazards (growing, harvesting, processing, all potential carry-overs, cross-that may be introduced by food storage, transportation) contamination allergens andor non-food materials, or by Does your supplier risk rework added to the processes /food contact, and to determine assessment show likelihood lines.the control mechanisms for the of cross-contact and can it be Assess and reference allidentified hazards. quantified? relevant raw materials, semi- Can your supplier’s procedures finished product and finished2.1.1. Identify allergen presence manage out this risk (cleaning, product specifications.from materials intentionally scheduling, dedication)?added to the finished product A separate assessment isrecipe (either ingredients, required for each allergen to ensure 2.1.3. Repeat the above for anyadditives, processing aids, cross-contact between different allergenic derivatives that may berework and holdover, etc.). Fully allergenic ingredients is also introduced via non-food/packagingdescribe the name or type of addressed, not only that between materials (either packagingmaterial, for example, flour is allergenic and non-allergenic materials for raw materials, rework,wheat flour. List carriers for foodstuffs. holdover, finished product, or otherflavours, for example: lactose. materials which become contact materials during production or 2.2.2. Identify the areas where Do the allergenic derivatives during consumer use). potential cross-contact maycontain allergenic protein? occur. Are the allergenic derivatives 2.1.4. Do this for every food Shared storage, handling, mixing,particulates / pieces, or difficult to and non-food material present on transportation.manage, e.g. sticky, oily? site, including raw materials and semi-finished ingredients. Cross-over / spillage points. If so, assess whether proceduresare capable of managing the risk of Shared cleaning equipment. 2.2. Identify potentialcross-contact. opportunities for cross- Shared production / packaging Do the identified allergens / contact within own operations equipment and lines.allergenic derivatives require (handling, storage, productionlabelling on pack? processes, packing). Airborne cross-contamination. Will the consumer expect Aim: To identify the key areas inthe allergen presence in this manufacturing where cross-contactproduct type i.e. is it “hidden”? If between allergen-containing andso, consider whether additional non-allergen ingredients andemphasis of allergen presence is products can occur, and identifyrequired in risk communication. likelihood of undeclared allergen presence in the finished product.p // 40
  • 41. 2.2.3. Construct an allergen Likely: likely under normal upon consumption of very lowcross-contact map for site. operating conditions. amounts, and to which a significant number of consumers in Europe Relevant HACCP documents or Unlikely: unlikely to arise but still are allergic; have been identifiedforms may be used to assist. possible. by the European Food Safety Authority (EFSA) and the European When constructing a map all 2.4. Determine the allergen Commission as requiring riskingredients, materials, rework, work hazard rating of any identified management through mandatoryin progress, processes and flow allergen cross-contact on-pack declarations. These areof people through manufacturing presence. listed in EU labelling legislation andwhich may present a risk of present a recognised risk of severeallergen cross-contact should be Aim: To evaluate the severity of the allergic reactions to Europeanconsidered. risk identified. Taken together the consumers which requires risk amount of hazardous allergenic management.2.3. Assess each potential food potentially present, and theissue identified in 2.2 against probability that they are present Other countries outside the EU havecritical elements per the table in the final product describe the different patterns of food allergyin section 3 of this appendix overall level of risk requiring control. and therefore other / additional foodfor compliance with the best allergens should be considered forpractice considerations and When assessing risk associated those markets.evaluate the probability for with allergens there are several keycross-contact as ‘likely’ or ‘ parameters which will influence 2.4.2. Allergen Proteinunlikely’. judgment regarding the severity: Presence amount of allergen (in practiceAim: To determine the probability amount of allergenic protein) The protein component of thethat allergen cross-contact will allergen potency and prevalence, allergenic food is responsibleoccur and ensure the control and physical form of allergenic for causing the reaction. Lowermeasures used for the minimisation ingredients. protein content = lower allergenicof the potential for cross-contact potential. Materials with levels ofare practical and sufficiently robust 2.4.1. Allergen potency and protein below analytical detectionto be effective. The rationale for the prevalence would therefore generally presentevaluation should be documented. low or very low risk potential. Potency refers to the amount of2.3.1. Are best practice allergenic food needed to provoke Some allergenic derivatives haveconsiderations in place? Are a reaction. been exempted from mandatorythere opportunities to improve allergen labelling on-pack on therisk management practices? Prevalence relates to the number basis of dossiers demonstrating the of individuals in the population lack of allergic reactions upon food2.3.2. What is the probability of who react to a specific allergen. challenge with these derivatives.cross-contact occurring under Allergens which are known to These are listed in EU labellingnormal operating conditions? provoke severe adverse reactions legislation.p // 41
  • 42. Examples include highly refined Determination of the possibility It should be recognised thatoils derived from allergens such of particulate contamination ongoing verification of controlas refined soya bean oil, or highly should not automatically lead to a measures will still need toprocessed allergen derivatives precautionary label. Assessment be undertaken, after allergensuch as wheat maltodextrin. These of the probability of such risk assessment has beenall have extremely low protein contamination, combined with completed and the requirementsconcentrations, and therefore the factors described in earlier implemented, using a variety ofhave low allergenic potential as sections, should be used to identify methods to ensure it is workingdemonstrated in clinical studies. risk from the final product. effectively in practice. This may include audit, data analysis and2.4.3. Physical Form of 2.5. Determine whether review, or additional sampling andAllergenic Ingredients appropriate control measures testing. are currently in place or canParticulates and fragments (nuts, be implemented to minimize 2.5.1. Identify control measuresseeds, chunks, solid agglomerates the risk of allergen cross- in place to manage allergenetc.) will usually remain intact contact. cross-contamination usingand could potentially appear critical elements in Table 2 as aas non-homogeneous (hot This is referred to as risk best practice guide.-spot) contamination. This will management and determinedpotentially deliver higher doses of through a process of monitoring, 2.5.2. Confirm effectiveness ofcontaminating allergenic material to validation and verification. control measures assignedthe consumer. Readily dispersible for minimising risk of cross–contamination includes powders or Validation work should be carried contamination through robustliquids in homogeneous form e.g. out and documented for each scientific validation.milk powder, soya flour. These are control measure/combination oflikely to appear evenly distributed control measures. Cleaning is a 2.5.3. Confirm ongoing verificationthroughout a product. Therefore commonly applied control measure procedures in place to assureconsideration needs to be given to as it usually provides the break allergen risk managementthe form of the cross-contaminating between allergen-containing and practices are carried out andmaterial and the form of the non-allergen-containing products. remain effective.product e.g. powder into powder, If the control measure has beenpowder into liquid or particulates implemented previously, the resultsinto powder. from this historical work can be used as an input into the validationTherefore, the following risk potential study. Guidance on undertaking aranking for the cross-contaminating cleaning validation study is set outmaterial is suggested: in appendix 6. Viscous Pastes Liquid / Particulates / Gels / Powder Agglomeratesp // 42
  • 43. 2.6. Determine risk 2.6.1. What should becommunication requirements mandatorily labelled in theto identify any intentionally ingredients declaration onpresent and unintentionally finished product pack?present allergens for theconsumer. 2.6.2. Are any additional advisory warnings of unintendedAim: To provide the necessary presence needed? If so, forinformation to consumers to allow which allergens?avoidance of products containingallergens. For further details on labelling requirements see Annex 3 and 6.3. Allergen Risk AnalysisIn table 2A below the critical elements are described It should be noted that the use of the table is notthat should be addressed during an allergen HACCP a substitute for expert judgement based on soundrisk analysis and that should be included in allergen risk information and experience, but rather a guide formanagement programmes. Best practice considerations structuring risk assessments. The table should not beare detailed, based on common causes of allergen risk used alone as an exhaustive list. Unique criteria will alsomanagement failures, and thus the table may serve as exist relevant to each product, production process, line,the basis for a checklist, which can be used by food and site and these must also be considered.operators to verify the capability of their allergen riskmanagement programme.Example of a risk assessment (Critical Element: Manufacturing)p // 43
  • 44. Table 2A Critical elements for HACCP Risk Analysis and Risk Managementp // 44
  • 45. p // 45
  • 46. p // 46
  • 47. p // 47
  • 48. p // 48
  • 49. p // 49
  • 50. 4. Considerations for Risk PreventionFollowing an analysis of food allergy incidents, the The checklists below in Table 2B are provided to act asmost common causes of allergen risk management a guide for food operators to verify that the likely causesfailure are considered to be (i) intended product in of these failures are considered and controlled withinintended pack that is wrongly labelled (ii) mismatch of their allergen risk management programme. They canproduct to packaging, and (iii) unintentional presence also be used to support root cause analysis in the eventof allergen in product. of a food allergy incident.p // 50
  • 51. p // 51
  • 52. p // 52
  • 53. p // 53
  • 54. p // 54
  • 55. p // 55
  • 56. Annex 3 Allergen Labellingp // 56
  • 57. Regulation (EU) 1169/20111 on the provision of food information to consumers considerably changesexisting legislation on food labelling, including information and requirements on allergens. The new ruleswill apply from 13 December 2014.The Regulation outlines requirements relating to allergens such as mandatory particulars, the labelling ofcertain substances or products causing allergies and intolerances, additional voluntary information andallergen labelling of non-pre-packed foods.SummarySubstances or products causing allergies must be The following articles are relevant for aller-indicated, also for non-prepacked foods; gen labelling 2:Each ingredient or processing aid originating from a Article 9.1(c): Mandatory particularssubstance or product causing allergies or intolerancesmust be: Article 21: Labelling of certain substances or products causing allergies or intolerances- Indicated in the list of ingredients with reference Article 36.3(a): Additional voluntary allergento the name of the substance or product as labelling (“may contain”)listed in Annex II; Article 44.1(a) and 44.2: Allergen labelling Emphasised through a typeset that distinguishes it of non pre-packed foodsfrom the rest of the list of ingredients; Annex II: List of substances or productsIf no list of ingredients is provided, the substance or causing allergies or intolerancesproduct causing allergies or intolerances must beindicated by means of “contains + [substance(s)/product(s)]”. 1 Regulation (EU) No 1169/2011 of the European ParliamentWhen the name of the food clearly refers to the and of the Council of 25 October 2011 on the provision of foodsubstance or product causing allergies or intolerances, information to consumers, amending Regulations (EC) Noit is not necessary to label the concerned substance 1924/2006 and (EC) No 1925/2006 of the European Parliamentor product. and of the Council, and repealing Commission Directive The European Commission must systematically 87/250/EEC, Council Directive 90/496/EEC, Commissionre-examine and, where necessary, update the list Directive 1999/10/EC, Directive 2000/13/EC of the Europeanof substances or products causing allergies or Parliament and of the Council, Commission Directivesintolerances. 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004. The European Commission must establish 2 For ease of reference, allergen labelling in this documentimplementing measures on the additional voluntary refers to the labelling of substances or products causing“may contain” labelling. allergies or intolerances.p // 57
  • 58. Article 9.1(c): Mandatory particulars 21.1: PRESENTATION OF THE LABELLING OF CERTAIN SUBSTANCES OR PRODUCTS CAUSINGIn accordance with Articles 10 to 35 and subject to the ALLERGIES OR INTOLERANCESexceptions contained in this Chapter, indication of thefollowing particulars shall be mandatory: Without prejudice to the rules adopted under Article[…] 44(2), the particulars referred to in point (c) of Article 9(1) shall meet the following requirements:(c) any ingredient or processing aid listed in Annex II orderived from a substance or product listed in Annex II Food business operators must indicate the substancescausing allergies or intolerances used in the manufacture or products causing allergies or intolerances in the wayor preparation of a food and still present in the finished specified in the following sub-paragraphs.product, even if in an altered form;[…] Where specific national measures have been introduced by individual Member States on non-pre-packed foodsFood business operators must label any ingredient or with regard to the form of expression and presentation ofprocessing aid: the allergens that have to be provided on a mandatory listed in Annex II; or basis (Art. 44.2), these precede over the requirements derived from a substance or product listed in Annex II of Article 21.The list of Annex II is outlined in Annex 3 to this (a) they shall be indicated in the list of ingredients inGuidance. Labelling of these ingredients, processing accordance with the rules laid down in Article 18(1),aids, substances or products causing allergies or with a clear reference to the name of the substance orintolerances is obligatory when they are used in the product as listed in Annex II; andmanufacture or preparation of a food and are still presentin the finished product, even if in an altered form. The ingredients that according to the Annex II of the Regulation are substances or products causingFurther rules on how to label are specified in Article 21. allergies or intolerances must be indicated in the list of ingredients “with a clear reference to the name of theArticle 21: Labelling of certain substance or product as listed in Annex II”. Hence, there are no changes in this respect compared to the currentsubstances or products causing allergen labelling situation in Directive 2000/13/EC.allergies or intolerances (b) the name of the substance or product as listedArticle 21 is the main article covering allergen labelling. in Annex II shall be emphasised through a typesetIt is structured as follows: that clearly distinguishes it from the rest of the list of ingredients, for example by means of the font, style or 21.1: Presentation of the labelling of certain background colour.substances or products causing allergies orintolerances The name must be emphasised through a typeset 21.2: Systematic re-examination and possible different than that from the rest of the list ofupdate of the list of substances or products causing ingredients, for example by means of the font, styleallergies or intolerances or background colour.p // 58
  • 59. Emphasis may best be achieved by indicating theingredients concerned in bold in the list of ingredients. Examples:However, food business operators may use other waysof emphasis, amongst others, for reasons of technical Strawberry-flavoured soy drink, where soyfeasibility, be it those mentioned in the provision (font, lecithin is used in the flavour;style, background colour) or others. Wheat flour;In the absence of a list of ingredients, the indication of All dairy products, e.g. cheese, yoghurt,the particulars referred to in point (c) of Article 9(1) shall cream, butter, as it is clear that they arecomprise the word ‘contains’ followed by the name of the derived from milk (see Annex XII and XIII ofsubstance or product as listed in Annex II. Reg. 1234/2007 for further explanation on the definition and designation of dairy products);When no list of ingredients is given (e.g. for glass Tuna paté.bottles intended for reuse which are indelibly markedand which therefore bear no label, ring or collar), theword “contains” followed by the name of the substance Furthermore, in those cases where the name of theor product causing allergies or intolerances must be ingredient clearly refers to the substance or productindicated. causing allergies or intolerances, it is also not required to label the concerned substances or products. The nameWhere several ingredients or processing aids of a food of the food is the legal name of the food as determinedoriginate from a single substance or product listed in Article 9.1(a) and Article 17. For example, when thein Annex II, the labelling shall make it clear for each name of the food contains words such as yoghurt,ingredient or processing aid concerned. cream, butter, cheese etc., it is clear for the consumer that these products contain milk.Where the food contains several ingredients orprocessing aids that originate from one substance or 21.2: SYSTEMATIC RE-EXAMINATION ANDproduct causing allergies or intolerances, the operator POSSIBLE UPDATE OF THE LIST OF SUBSTANCESmust either repeat the reference to the substance or OR PRODUCTS CAUSING ALLERGIES ORproduct as many times as it is present or choose any INTOLERANCESother presentation which makes clear that differentingredients or processing aids originate from one single In order to ensure better information for consumersallergen. and to take account of the most recent scientific progress and technical knowledge, the CommissionThe indication of the particulars referred to in point shall systematically re-examine and, where necessary,(c) of Article 9(1) shall not be required in cases where update the list in Annex II by means of delegated acts,the name of the food clearly refers to the substance or in accordance with Article 51.product concerned.In those cases where the name of the food clearlyrefers to the substance or product causing allergies orintolerances, it is not required to label the concernedsubstances or products.p // 59
  • 60. The European Commission must systematically Food information provided on a voluntary basisre-examine and, where necessary, update the list shall meet the following requirements:of substances or products causing allergies or (a) it shall not mislead the consumer, as referred tointolerances. in Article 7;Here, it needs to take into account: (b) it shall not be ambiguous or confusing for the the objective of ensuring better information for consumer; andconsumers; and (c) it shall, where appropriate, be based on the the most recent scientific progress and technical relevant scientific data.knowledge, supported by an EFSA Opinion. Then, Article 36.3 covers the implementing measuresWhere, in the case of the emergence of a risk to that the European Commission must adopt in order toconsumers’ health, imperative grounds of urgency facilitate the application of these requirements:so require, the procedure provided for in Article 52shall apply to delegated acts adopted pursuant to The Commission shall adopt implementing acts onthis Article. the application of the requirements referred to in paragraph 2 of this Article to the following voluntaryIf there is an urgent need due to emergence of a risk food information:to consumers’ health, the urgency procedure must beapplied. This means that the European Commission is (a) information on the possible and unintentionalable to adopt a delegated act in relation to Article 21 presence in food of substances or products causingwithout delay, as long as no objection is expressed by allergies or intolerances;the European Parliament or the Council. […]Article 36.3(a): Additional voluntary According to Article 36.3(a), the European Commissionallergen labelling (“may contain” must adopt implementing measures detailing the– information on the possible and application of the requirements related to voluntaryunintentional presence of substances information on “may contain” labelling (i.e. the possibleor products causing allergies or and unintentional presence in food of substancesintolerances) or products causing allergies or intolerances). FoodDrinkEurope supports the development ofArticle 36 covers the applicable requirements for European guidance related to “may contain” labelling.voluntary food information and the implementingmeasures that the European Commission needs to takeon the application of the requirements.First, Article 36.2 covers the general requirements thatvoluntary food information must meet:p // 60
  • 61. Article 44.1(a) and 44.2: allergen Of particular relevance for allergen labelling is Article 44.1(a), which specifies that information concerninglabelling of non pre-packed foods allergens must be available for non-prepacked foods.Article 44 covers national measures for non-pre-packed 2. Member States may adopt national measuresfoods. concerning the means through which the particulars or elements of those particulars specified in1. Where foods are offered for sale to the final paragraph 1 are to be made available and,consumer or to mass caterers without prepackaging, where appropriate, their form of expression andor where foods are packed on the sales premises the consumer’s request or pre-packed for directsale: Paragraph 2 of Art. 44 indicates that Member States may adopt national rules concerning the means of(a) the provision of the particulars specified in point communicating the particulars such as the allergen(c) of Article 9(1) is mandatory; declaration (e.g. leaflet, website, etc.) and their form of expression and presentation.(b) the provision of other particulars referred to inArticles 9 and 10 is not mandatory unless MemberStates adopt national measures requiring theprovision of some or all of those particulars orelements of those particulars.p // 61
  • 62. Annex II of Regulation (EU) 1169/2011: substances or products causing allergies or intolerances is obligatory when they are used in the manufacture orList of Allergens and Exemptions preparation of a food and are still present in the finished product, even if in an altered form.It is important that information on the presence of foodsproven to produce an adverse allergenic or intolerance Note: This list will be systematically re-examined and,reaction should be available for sensitive consumers, where necessary, updated taking into account theto make informed choices which are safe for them. The objective of better information for consumers andlist of allergenic foods and foods causing intolerance the most recent scientific progress and technicalwhich require mandatory declaration in the EU is found Annex II of Regulation (EU) No 1169/2011, seebelow. Labelling of these ingredients, processing aids, 1 Cereals containing gluten, namely: wheat, 7 Milk and products thereof (including rye, barley, oats, spelt, kamut or their lactose), except: hybridised strains, and products thereof, (a) whey used for making alcoholic distillates except: including ethyl alcohol of agricultural origin; (a) wheat based glucose syrups including (b) lactitol. dextrose1; 8 Nuts, namely: almonds (Amygdalus (b) wheat based maltodextrins1; communis L.), hazelnuts (Corylus avellana), (c) glucose syrups based on barley; walnuts (Juglans regia), cashews (Anacardium (d) cereals used for making alcoholic distillates occidentale), pecan nuts (Carya illinoinensis including ethyl alcohol of agricultural origin. (Wangenh.) K. Koch), Brazil nuts (Bertholletia 2 excelsa), pistachio nuts (Pistacia vera), Crustaceans and products thereof; macadamia or Queensland nuts (Macadamia 3 Eggs and products thereof; ternifolia), and products thereof, except for nuts used for making alcoholic distillates 4 Fish and products thereof, except: including ethyl alcohol of agricultural origin; (a) fish gelatine used as carrier for vitamin or 9 Celery and products thereof; carotenoid preparations; (b) fish gelatine or Isinglass used as fining 10 Mustard and products thereof; agent in beer and wine. 11 Sesame seeds and products thereof; 5 Peanuts and products thereof; 12 Sulphur dioxide and sulphites at 6 Soybeans and products thereof, except: concentrations of more than 10 mg/kg or 10 (a) fully refined soybean oil and fat1; mg/litre in terms of the total SO 2 which are to be calculated for products as proposed ready (b) natural mixed tocopherols (E306), for consumption or as reconstituted according natural D-alpha tocopherol, natural D-alpha to the instructions of the manufacturers; tocopherol acetate, and natural D-alpha tocopherol succinate from soybean sources; 13 Lupin and products thereof; (c) vegetable oils derived phytosterols and 14 Molluscs and products thereof. phytosterol esters from soybean sources; 1 And the products thereof, in so far as the process (d) plant stanol ester produced from vegetable oil sterols from soybean sources. that they have undergone is not likely to increase the level of allergenicity assessed by the Authority for the relevant product from which they originated.p // 62
  • 63. p // 63
  • 64. Annex 4 Allergen Change Over (Cleaning/Flushing) Validationp // 64
  • 65. Purpose DefinitionsThis annex provides guidance on how to validate Validation: Confirmation by examination and throughchange-over practices (cleaning, flushing) where provision of objective evidence that the allergenallergens and non-allergens products are produced change-over is effective.on common food manufacturing equipment and to Verification: Confirmation by examination and throughdetermine quantitatively the level of carryover in order the provision of objective evidence that the requirementsto assess and, if necessary, mitigate the resulting risk. of the allergen change-over are applied at all times.General Considerations for Designing a Validation StudyThe determination of carryover levels from a product If an analytical study is required, accurate and robustwhich contains an allergen to another one is critical analytical results are only useful if the samplesfor quantitative assessments of allergen risks. A analysed have been taken as part of a correctlyvalidation study should be completed to confirm that designed study. Therefore, the sampling proceduresthe changeover practices occurring between recipes and subsequent analyses shall be appropriatelywhich contain a specific allergen and those which do selected and implemented.not are effective to control the risk. For conducting the validation at a manufacturing lineA qualitative risk assessment is recommended as a the “worst case” scenario should be chosen, i.e. thestarting point, followed by a semi-quantitative one in most difficult to clean recipe and the recipe with theorder to determine whether or not an analytically based highest concentration of the allergen used on thatvalidation study is required or applicable. For example, it line, followed by a recipe which does not contain themay be possible to estimate levels of allergen carryover allergen (marker protein).from one production run to another by ‘worst-casescenario calculations’ i.e. measuring how much material When no commercial test kit for the analytical validationis left behind in a process (e.g. based on film thickness is available and no other marker protein can be used,on equipment or weighing brushed out residual), what allergen line validations should follow the visualthe levels of such material would be after dilution with inspection protocol only and then comply with thethe next product (or in the next process step), whatamount of the material is allergen and therefore allergen visibly-clean Standard.levels in the final product that could be consumed. Heterogeneously distributed contamination (for example,Validation typically consists of a visual inspection pieces of nuts) might not be sufficiently captured by(physical validation) of accessible direct and indirect sampling depending on the size of particulates andfood contact surfaces and quantitative analytical thus analytical testing might not provide reliable data.testing using appropriate methods, such as ELISA, In such cases, visual inspection and confirmation thatand protocols (analytical validation). Rapid lateral-flow the visibly clean Standard is met (no product residue)devices testing may be used to support verification, but should be considered as the only pass criteria for aare not appropriate tools for validation (see annex 5). successful validation study.p // 65
  • 66. The validation should be considered part of the plants’ Validation of all individual lines might not be necessary,HACCP programme and repeated on a regular basis (for if they are essentially of the same design. Different linesexample, every two years), and if changes in formulation, might need to be assessed individually depending onprocess, equipment or change-over procedure occur. the nature of the differences in the design and howThe documentation should be maintained at each these will affect cleaning and carryover effectiveness.manufacturing location. Obtain or develop a flow diagram showing all the equipment associated with the product manufactured.ALLERGEN Determine if the flow diagram is accurate by walking the lineCHANGE-OVER No Update(CLEANING/FLUSHING) Flow diagram accurate? the flow diagramVALIDATION Yes Identify equipment that need disassembly, special attention or are difficult to access. Use the information in prepare or review cleaning procedure and inspection forms. Use photos to Using the flow diagram, prepare an supplement, if possible. inspection form or update the existing inspection form. Run the allergen containing product and perform an allergen changeover (cleaning/flushing) No Strip down the equipment and perform a Inspection If the equipment cannot be visual inspection utilising the inspection form form inspected every time it is cleaned, after the allergen changeover accurate? the verification of the cleaning parameters must be included in the inspection form (i.e. CIP time/ No Level of cleanliness temperature, concentration achieved? of chemicals, flushing material Yes quantity). The inspection should include the verification that Take samples based on worst case scenario appropriate labels are in place. and target allergen (marker protein) No Samples meet acceptable criteria? Yes Repeat sampling two times after an allergen changeover to confirm the results No Samples meet acceptable criteria? Yes Validation completedp // 66
  • 67. I Guideline for Physical Validation1. A flow diagram showing all areas may be used for training 6. Once the physical validationequipment associated with the purposes and placement in the is complete, the cleaning protocolprocess used to manufacture cleaning procedure as appropriate. and pre-operation checklistproduct on a production line should be used for each allergenshould be developed. Equipment 3. Existing documentation, like changeover.that comes in direct contact cleaning procedures (includingwith allergens as an ingredient specific instructions for 7. If validated commercialor finished product should be disassembly), pre-operation check allergen test kits are available forhighlighted. Components through sheets, HACCP check sheets, post the allergen(s) (marker protein),which product or ingredients do cleaning check sheets, should be the analytical validation step asnot flow, but where material can updated by utilising the information described in Section II shouldaccumulate must be included gathered above. follow.(e.g. vacuum filters in pneumatictransport systems). Highlighted 4. The updated detailed pre-areas should receive a detailed operation inspection sheet shouldallergen cleaning and a visual be validated by a physical walkinspection or a cleaning combined through of the line, with trainedwith flushing where areas exist, employees who are knowledgeablewhich cannot be accessed for about manufacturing, quality andcleaning and inspection. By the allergen change over process.utilising the flow diagram, a Corrections should be made aswalkthrough of the production needed in the pre-operation formline during the cleaning process to account for any learning.(with cleaning procedure) withemployees knowledgeable about 5. Relevant cleaning parametersthe cleaning and manufacturing should be documented in theprocess should be undertaken to cleaning procedure to assureensure completeness. removal of allergens and this should be considered as part of2. Equipment that will need the cleaning protocol needed fordisassembly, special attention, an effective allergen clean (e.g.or access to be cleaned and caustic wash at 2 % v/v, 75°C, forwhere sampling for the analytical 10 minutes). When the equipmentvalidation shall be done should cannot be inspected after cleaning,be identified and made note of. adherence to these parametersSpecific steps or actions needed should be verified after eachto effectively clean the line must cleaning, for example, for complexbe included in the change-over CIP (clean in place) installations.procedure. Photographs of theidentified difficult to clean or accessp // 67
  • 68. II Guideline for Analytical Validation1. The validation sampling should be cleaned for the allergen sanitising of the swabbed surfacesmeet acceptable criteria for changeover (after sampling is required.three (3) consecutive runs. In the production will be resumed with a c) If an external lab is used,absence of operational actions similar allergen profile). If this is swabs should be kept cool duringlimits (e.g. VITAL) for the specific not possible, the samples should shipping and tested within 24allergen all test results should be be analysed as soon as possible, hours. Shipping information shouldless than the limit of quantification and either the test results awaited be obtained from the lab before(LOQ) of the specific validated, before resuming production or sampling.quantitative test method. the product placed on hold until the results are available. Another d) NOTE: Though delivering2. If contamination is deemed to alternative would be to clean the quantitative results, surfacebe non-homogeneous the number line a second time and re-check it. swabbing is a comparative methodof samples per validation should and should not be done in isolationbe increased to maximise to 5. When the allergen validation is from product or rinsate testing. Itprobability of detecting residual performed the product containing might be that swabs will be positive,contamination. This may include the allergen should be tested for the while the first product througha combination of swabbing and presence of the allergen. Therefore the line will meet acceptableproduct/flushing mass testing. If a pre-cleaning sample should be criteria. In risk assessment terms,the physical constitution of the taken as a positive control. This will the important consideration iscontaminant will not allow for serve to ensure that the test kit is the extent to which any residuerepresentative samples (large effective in detecting the specified transfers to the product.pieces, chunks), analytical testing not recommended. Instead a 1.2. Rinsate (e.g. CIP, cratequantitative risk assessment should 6. Options for sampling and testing washing machines, manual foambe done by evaluating the amount are: cleaning regimes)of pieces or chunks, their size andtheir distribution in a sample along 1.1. Swabs (surfaces) a) Two representative (e.g. coveringwith an estimate of the occurrence. all CIP loops) rinsate samples from a) For product contact surface the final rinse should be collected swab samples (10 cm X 10 cm) are3. Disinfection agents may interfere to be taken after the line has been and tested.with analytical tests and should be cleaned. b) For testing purposes, the pH isrinsed off before sampling. Labs or required to be between 6.0 and 8.0.kit suppliers should be consulted to b) Take swab from representative If the pH is outside these limits, itconfirm. product contact locations. Target is required continue to rinse the surfaces on a worst case scenario system until the pH of the final rinse4. To minimise potential product basis (difficult to clean, rough or is 6.0 – 8.0. If the final rinse doeshold in case of results not meeting pitted surfaces/welds, bends or not fall in that range, the final rinseacceptable criteria, there is the anywhere where the product could time needs to be revised.option to simulate a changeover by hang up). If swabbing bufferscleaning as the line would normally contain additives, a re-clean orp // 68
  • 69. c) Testing should be done within b) If samples are taken at various c) The validation is passed, if at24 hours. If samples need to be times, the validation is passed if minimum the last two samples (withshipped to an external laboratory, at minimum, the last two samples the examples above: after 5 and 10they should be collected, stored (with the examples above: after 5 minutes) meet acceptable criteria.and shipped to avoid degradation, and 10 minutes) meet acceptable d) Time and amount of materialfor instance by using a refrigerated criteria based on agreed reference utilised for the flushing should becourier. values. All products tested before recorded and documented and the those two samples shall not be allergen change over procedure for1.3. Final Product used as finished product for the future production runs should be product of concern.An appropriate sampling plan changed accordingly.should be developed and applied, 1.4. Flushing with inert materialand its performance and limitations (e.g. product, salt, sugar)clearly understood. a) Perform a cleaning first to removea) Samples of the finished product as much residue from productfrom first product coming off the contact surfaces and adjacentline should be taken. Depending areas as possible.upon product type and situations(e.g. held-up areas down the line) b) Once the line starts, collectthe number of samples and times first flushing material samples atwhen samples are taken may vary. reasonable intervals after start up,As an example: samples taken at as an example after 1.5 and 100,1, 5 and 10 minutes, minimum 3 minutes.samples per time-period (for a totalof about 1 kg/time period).p // 69
  • 70. Annex 5 Allergen Analysisp // 70
  • 71. Introduction The Analytical LaboratoryThis annex is intended to give an overview of the Laboratories conducting analysis of allergens should beanalytical techniques and protocols that can aid appropriately equipped, have the facilities to performdecision-making in the management of allergenic/ this type of analysis and have staff trained accordingly.foodstuffs or those causing intolerances. However, due Any laboratory performing such analysis should beto the complex nature of food products and the broad accredited according to ISO 17025, and additionally,range of food business operators, the annex will not specifically accredited for the methods it performs.cover specific analytical questions. It should also be able to demonstrate regular and successful participation in proficiency tests for theseAnalytical techniques used for detecting the presence methods.or absence of residual or cross-contaminatingallergenic or intolerance substances vary. A “visually The laboratory should handle all tasks according toand physically clean” standard forms the basic starting Good Laboratory Practice or equivalent guidelines.point for allergen management and can provide a goodbasis for safe operation once it has been validated and Additional laboratory requirements specific to theperiodically verified, using one (or more) of the methods methodologies used will be described in the appropriatedescribed. Absence of an allergen above a specified section of this annex.detection limit on visually clean equipment can be usedas the basis for a limited quantitative risk assessment if It is good practice before a laboratory is tasked withthe sampling is representative. analysis to obtain confirmation on its ISO 17025 accreditation for allergen analytical methods as wellThe methods and techniques mentioned can also as several results from proficiency test programmes foraid in the confirmation of material composition, batch allergens (e.g. FAPAS1) should be requested.qualification and to contribute to the due diligence ofany product claims. Analytical techniques for allergenanalysis continue to be developed and it is advisable forall users to keep up-to-date with Regional and Nationalinitiatives on methods, matrixes and analytic validation.Another issue, impacting on the comparability ofmethods is the availability of reference materials.The European Commission-funded 6th FrameworkProgramme Network of Excellence, MoniQA( has produced andvalidated reference materials for allergen detectionmethods for milk in an inter-laboratory study with 5 1 FAPAS: Food Analysis Performance Assessment Scheme;ELISA kits across 20 laboratories worldwide. Furtherreference materials are being produced for other allergen and intolerance targets.p // 71
  • 72. it has not previously analysed. Ideally, manufacturersFood Matrices should provide a control sample of the matrix in which cross-contact allergen is to be measured, which is knowFood matrices can have a significant impact on the not to contain the allergen under investigation. Thisanalytical result. Also, the choice of methods and sample serves to check for the presence of the allergensampling procedures often depend on the information in the raw materials and to demonstrate spiking withregarding the food matrix. and recovery of the allergen.While liquid samples are usually consideredhomogeneous or can easily be homogenised by stirring, Samplingcomposite samples where components have differentcharacteristics are more difficult to handle. Muesli bars, Testing protocols can play an important part infor instance, have typically several different dispersed the validation and on going verification of allergeningredients and may have a very inhomogeneous management plans and need careful consideration.distribution of allergens in only one component. For The meaningfulness of analytical results is highlyanalysis, these need to be fully homogenised before a dependent on the sampling process. A sample takentest sample is taken for analysis. in a non-representative way (e.g. too small, only single location) is unlikely to give an analytical result that isThe matrix may also have components which make it representative for the production process. Therefore,unsuitable for certain types of analysis and may give sample sizes and locations where the samples are takenrise to either false positive or negative results These should be representative, as should any intermediate orcomponents can sometimes either mask the allergen final product samples.if present (i.e. tannins or polyphenols) or appear verysimilar to the allergen being detected (false positives). Sampling, i.e. location and frequency, should be basedOther components also influence results: high acidity on risk assessment. As an example, strictly separatedimpacts on DNA detection as it destroys the DNA while components with no risk of contamination by allergensproteins may still be present. High sugar can also need only be sampled on an infrequent basis forinterrupt DNA clean-up, depending on the process. confirmation, while commonly used equipment (e.g.Ethanol denatures antibodies leading to a false-negative conching equipment, mills, mixers) on or in whichresult. Therefore, it is absolutely essential to provide the allergens are also being used, should be sampled morelaboratory with information on the composition of the frequently. The risk and frequency should be identifiedsample to allow it to choose the best methodology2. in the allergen management plan (see core document).To reduce the risk of generating false negative or falsepositive results due to matrix effects, each matrix shouldideally be validated to demonstrate that the allergenis detectable by the method chosen. Although it isnot practically feasible to validate all matrices as thenumber of possible matrices is infinite, a laboratoryshould have sufficiently demonstrated its ability toanalyse for the allergen in comparable matrices (e.g. 2 Ideally, a free (confirmed by other approach) allergen samplehigh sugar, high fat, acidic). It is however advisablefor the laboratory undertaking the analysis to perform of food matrix spiked with the allergen should be given to thea small-scale validation on new or novel matrices that lab to validate sampling preparation and detection.p // 72
  • 73. Samples should be taken using clean equipment, If the allergen containing product is likely to spreadpreferably single use spoons or spatulas. Samples beyond the immediate production equipment (e.g.should be placed in clean, also preferably single powder or spray), the risk areas should be swabbed touse, containers to avoid false positive results through identify any possible contamination.contaminated sample equipment and storagecontainers. Samples should be sent to the laboratory For dry manufacturing processes, it may be morein conditions that prevent deterioration of samples. Dry appropriate to monitor levels of allergen contaminationsamples tend to be less susceptible to deterioration using settle plate or air monitoring samples.compared to liquid or moist samples. While theformer can be sent without chilling, the latter should, To confirm the effectiveness of cleaning, quantitativedepending on the expected transport time, preferably analysis is required, showing the reduction of allergenbe sent chilled. after cleaning. Care has to be taken as some cleaning agents can negatively influence the ELISA and PCR leading to false negative results. Before cleaningType of Samples: validation, the laboratory should be consulted to advise on possible adverse effects of cleaning agents.The type of sample taken for analysis will ultimatelydepend on the specific activity being monitored and b) Cleaning validation samples: Heterogeneousthe manufacturing environment. This can be broadly Cross-Contamination Assessment.categorised as follows: Environmental Swabs – monitoring residual allergens In the event that the risk of allergen contaminationon food contact surfaces. is deemed to be heterogeneous (particulates, nuts, seeds etc.), the approach outlined in section (a) also Purge Materials/ Flushing Mass – monitoring system needs to include a detailed visual inspection andwhere wet cleaning is not appropriate. physical strip down of equipment. This will highlight Air Samples/ Settle Plates – used to monitor dusting. those points in the process where more rigorous sampling is required. For further guidance refer to the CIP Rinsate – used to monitor effectiveness of annex on cleaning validation.clean-in-place systems. Finished product – used to monitor effectiveness of c) Confirmation of absence samples/routinecleaning following cleaning in conjunction with other environmental monitoring/verification samplessamples listed above. If a process has been validated and demonstrated to nota) Cleaning validation samples: Homogeneous contain detectable amounts of allergens, routine controlCross-Contamination Assessment checks may be advisable for verification purposes. These checks can be conducted on site by lateral flowFor cleaning validation of a re-occurring process (e.g. devices (LFD) for the suspected allergen or by non-changing production from allergen containing product specific total protein assays or by total protein assaysto non-allergen containing product), samples should provided product does not contain protein. Positivebe taken before the cleaning process, and after the findings should be confirmed by a specific analysis incleaning process. Samples should comprise the initial the laboratory as some generic tests also can lead toproduct, washing solutions (or cleaning/ flushing false positive results.materials like fat, sugar if water based cleaning is notpossible) and the subsequent product.p // 73
  • 74. Technology According to Technologies in Detail -Purpose Advantages andGenerally, protein or peptide detecting methods are Disadvantagesto be preferred over DNA detection methodologies Protein Based Methods(usually polymerase chain reaction, PCR) since thepresence of DNA may not indicate the presence of Since all food allergens listed in annex IIIa of 2007/68/allergenic protein, and a negative PCR result may not EC are, with the exception of sulphur dioxide andindicate the absence of protein3. sulphites, proteins, protein is the primary analyte that should be targeted. Protein based methods can be divided into two groups: immunological methods andTechnologies Recommended protein separation methods. Immunological methodsfor Typical Purposes are antibody-based, i.e. an antibody, similar to the one causing the allergic reaction in humans, detects the proteins. Typical methods are ELISA (Enzyme Linked For validation of cleaning processes, or for ingredient Immuno Sorbent Assay) and LFD (Lateral Flow Device;or finished product testing enzyme linked immune- commonly known as dipstick/ rapid lateral flow devices).sorbent assays (ELISA) should be used as the technique Immunological methods are long established in manyis generally quantitative. routine laboratories and are the method of choice for For routine cleaning verification checks, LFDs can industry and regulatory bodies because of the specificitybe used on site but should be supported by regular and sensitivity of the antibodies. They are used inconfirmation by ELISA. food industry laboratories and by official food-control bodies to detect and quantify allergens present in food. In case of ambiguous results by a protein-based Protein separation methods like mass spectrometrymethod, PCR results can serve as a secondary (MS) are based on the separation of proteins or theirconfirmatory check. However, this typically only makes fragments (peptides) due to their variable size andsense, due to PCR sensitivity for certain allergens, when charge. They are mostly used as an alternative methodELISA results are higher than 10-20 mg/ kg (ppm). of analysis when an ambiguous result is recorded by PCR should only be used where no other protein other methodology. Recent developments in LC MS-MSdetection technology is available (e.g. celery detection methodology have shown encouraging results, and inor tree-nuts other than almond, hazelnut, walnut). the future, it is likely that it will serve as a confirmatory method for the analysis of formal samples. Mass spectrometric methodology, as it is not a routinetechnology yet, should be used where secondaryconfirmatory checks are required where results differ 3using conventional methodology. NOTE: The European Directive 2007/68/EC for the labelling of food allergens does not differentiate between LFD should be used on site for routine cleaning proteins and other compounds (e.g. metabolites orvalidation checks and can also be used for release DNA). Any derivative requires labelling if part of thetesting of finished products. ingredient listp // 74
  • 75. ELISA Lateral Flow Devices (LFD)ELISAs have been much favoured in allergen analysis. LFDs (also called dipsticks) are a rapid immune-The specificity and sensitivity of ELISA technology, chromatographic technique, available as a single-with limits of detection or quantification at low mg/ use format device that allows qualitative detectionkg level, make it a simple tool for allergen detection of the allergen. The typical LFD is a colorimetric testand quantification, allowing relatively fast and high that contains a control line (ensuring the validity of thethroughput analysis. It is widely used in food industry assay) and a test line, which determines the presence/laboratories and by official food-control bodies to detect absence of the target allergen. These assays areand quantify allergens present in allergenic food or typically used on site for rapid analysis (typicallycommodities. So far, ELISA test kits validated for defined absence of allergen). While the costs of LFDs are lowermatrices include peanut (in cereals, cookies, ice cream than ELISA, they provide only a yes/ no answer. In someand chocolate; under the auspices of AOAC and EC instances, results may vary depending on the LFD lotJRC, Park et al 2005, Poms et al 2005) and hazelnut (in used. Therefore a regular comparison of LFD with ELISAcereals, ice cream and chocolate; under the auspices of results is recommended.the German Federal Office for Consumer Protection andFood Safety, BVL). However, many others are routinely LFDs should be used when quick on-site presence/used by food laboratories. absence checks for individual allergens need to be performed as part of the continuing risk assessment.It is important to realise that ELISAs have somedrawbacks: these include that only one target allergencan be detected/quantified per test, i.e. a compositefood containing potentially 5 allergens require 5 differentELISA assays which may provide a resource challenge.In addition, several companies offer antibody kits for thesame allergen, all with somewhat different specificitiesand sensitivities. This can generate divergent resultsif the same sample is tested using two different kits.Frequently found differences are between ELISA kits forthe detection of gluten. Here, alternative methods likeMS could be used for confirmation.Results can also be influenced by a number of otherfactors. If, for example, only the whey fraction of milkis used but the ELISA test detects casein since thelaboratory does not have the relevant information, it maygenerate a false negative result. Hydrolysis and oil/ fatfractions are further examples.ELISA should be used when quantitative results arerequired, like for cleaning validation procedures, and toconfirm results of other methods, like LFD.p // 75
  • 76. Mass Spectrometry (MS) DNA Based MethodsIn the near future, MS methods will likely play an important The most popular DNA-based techniques are PCRrole, providing a viable alternative confirmatory method and real-time PCR. Both are used qualitatively forsince MS has the potential to directly detect proteins/ the detection of food allergenic compounds. Thesepeptides (and therefore, the hazard itself) at low levels techniques typically amplify a part of the species-similar to those achieved by ELISA and PCR. The high- specific- or allergen-encoding DNA sequence.test potential of mass spectrometry lies in its capabilityto analyse multiple targets (multiple allergens) in The detection of food allergens by DNA-baseda single analysis (the so-called ‘screening’). This techniques is controversial because they do not detectdistinguishes mass spectrometry from ELISA, and as the target protein but the marker DNA that may or maya direct detection tool, from PCR. Another advantage not correlate with the amount of the allergen in theis that, unlike antibody based technologies, processing food product. Examples are those food componentshas a lesser impact since MS detects the weight, not that are formulated with protein-rich ingredients,the structure which is often changed during processing. e.g. egg- or milk powder. The quantity of DNA in theThe accurate detection of the allergen relies on the sample, the presence of interfering compounds inidentification of peptide fragments which are cleaved the DNA preparation as well as its quality determinesby the enzyme trypsin during sample extraction. the success of the assay. An advantage of PCR overStudies on highly processed foods where the peptides ELISA is that all the assay components are availablebecome highly modified, can impede the cleavage of commercially and it is easy to develop. PCR is the onlythe peptides and hence detectability of the allergen. As alternative for those regulated allergens for which ELISAwith other methods matrix validation must be conducted is not available (e.g. celery). One of the drawbacks ofto provide confidence in the analytical results. PCR detection is that DNA is highly unstable in acidic environments (e.g. tomato sauce). Here, protein orMS also has the potential to be semi- or fully automated peptide based assays should be used if at all possible.potentially allowing high throughput of samples. As with Also, issues can arise in laboratories from crossany new methodology, its future application on analysis contamination when small amounts of target DNA fromof food allergens is still somewhat restricted due to high previous assays contaminate the PCR mix and generateequipment costs and the need for specialist expertise false positive results. Other issues are found with animalin method development. However, easy-to-use toolkits products which trigger allergic responses while othersare already in the pipeline by several major equipment from the same animal, do not. As an example, PCRmanufacturers, essentially simplifying the use of the analysis cannot distinguish between DNA originatingmethodology for the non-expert user. from non-allergenic beef meat and allergenic milk, or non-allergenic chicken meat and allergenic egg4. Laboratories operating PCR equipment should have at least four separate areas, ideally separate rooms for sample preparation, PCR mix preparation, PCR and post PCR handling (e.g. gel electrophoresis)5. Therefore, PCR analysis should only be requested where needed and the laboratory conducting the analysis should have geographically separated areas to minimise the risk of cross-contamination with amplified DNA.p // 76
  • 77. DNA methods should be used if no alternative proteinmethods are available or as supporting information toconfirm ELISA/ LFD results when contamination levelsof 10mg/ kg (ppm) or higher are expected. 4 NOTE: Egg is actually unsuitable for PCR analysis as mentioned earlier since it contains very little, or in case of egg white, no DNA despite having a high allergenic potential due to the presence of specific proteins. 5 EN 15634-1: Foodstuffs - Detection of food allergens by molecular biological methods; Part 1 - General Considerations; Section 4.2 Laboratory Organisationp // 77
  • 78. Analytical Technologies at a Glance All techniques can be prone to interferences (false positive/ negative), which is why rigorous validation is required.p // 78
  • 79. p // 79
  • 80. Annex 6 Gluten-Free Foodsp // 80
  • 81. This annex provides an overview of the rules governing the use of claims to indicate the suitability offoods for people intolerant to gluten and the compositional requirements that must be met in order to usesuch claims.It must be noted that the legislative framework covering the rules on the composition and labelling offoodstuffs suitable for people intolerant to gluten is currently being reviewed by the European Commission.The location of the gluten provisions will be affected by this review. Further information is provided insection 3 below.1. EC Regulation 41/2009 Concerning the Compositionand Labelling of Foodstuffs Suitable for People Intolerantto Gluten 1a) Background b) PurposePrior to this Regulation there were no legally defined This Regulation aligns EC legislation with the newcompositional standards for gluten- free foods, Codex Standard. Harmonisation at an EU level of thehowever manufacturers were encouraged to work to conditions under which the terms ‘gluten free’ andthe international standard set by Codex Alimentarius. ‘very low gluten’ can be used will ensure a high levelThis standard was recently revised to take account of of protection for people intolerant to gluten. In addition,the latest scientific advice. The new standard2, adopted consistent labelling will help consumers with differentin July 2008, sets a maximum level of 20mg/kg of sensitivities to gluten to make informed choices aboutgluten in order for food to be labelled as ‘gluten free’, the foods that are most suitable for them.and 100mg/kg of gluten for foods labelled as ‘very lowgluten’- restricted to foods processed to remove gluten. c) ScopeUse of the term ‘gluten- free’ is permitted by Regulation The Commission Regulation applies to all foods(EC) No 41/2009 which applies to food for people (including alcohol, food supplements, etc.), pre-packedintolerant to gluten. Coeliac disease is a permanent and non pre-packed, except infant formulae and follow-food intolerance, where scientific evidence has shown on formulae. However, the PARNUTS Frameworkthat very low amounts of gluten up to 20 mg/kg are safe Directive states that PARNUTS3 shall only be sold pre-to these consumers. Gluten-free foods may, therefore, packed, unless Member States provide exemption fromcontain levels of gluten, which are above the limit of this rule.detection of the analytical tests used, but less than thenew Codex Standard for ‘gluten- free’ foods of 20mg/kg.1 EC Regulation 41/2009/EC concerning the composition and labelling of foodstuffs for people intolerant to gluten: CODEX STAN 118-1979: Parnuts are foodstuffs which are intended for particular nutritional uses, which owing to their special composition or manufacturingprocess are intended to satisfy the particular nutritional requirements of specific groups of the population.p // 81
  • 82. The Commission Regulation applies to the labelling, the final consumer. The term ‘very low gluten’ can onlypresentation and advertising of foods. Therefore, the be used for PARNUTS foods, prepared specifically forprovisions related to the use of the claims ‘very low those intolerant to gluten, and with a level of betweengluten’ and ‘gluten free’ do not apply solely to the 20mg/kg and 100mg/kg in the food as sold to the finallabelling of foods but also to any form of advertising consumer. A flow chart to help you to determine theand presentation, which includes, for example, most appropriate claim for your product is enclosed asoff-pack labelling, such as websites, leaflets, product Figure 1.lists, customer care lines and shelf labels. The term ‘suitable for coeliacs’ (or logos which are intended to indicate this) can only be used inWhen the claim ‘gluten- free’ is used, this must not conjunction with the claims permitted by the Regulationmislead the consumer by suggesting that the particular (i.e. alongside ‘gluten free’ or ‘very low gluten’).food is special in having that property, when all otherfoods of that type are also ‘gluten free’. These new rules came into effect on 9 February 2009. Manufacturers had until 1 January 2012 to comply with the new requirements, but were allowed to use the newd) Requirements terms from February 2009, provided that the productsUnder this Regulation, the term ‘gluten-free’ may only comply with the compositional criteria. Products thatbe used for PARNUTS foods or ‘normal foods’4 with a did not comply by 1 January 2012 should have beenlevel of gluten below 20mg/kg in the food as sold to removed from the market.2. Other Relevant Legislation• PARNUTS FoodsPARNUTS Framework Directive: Directive 2009/39/EC on the approximation of the laws of the Member States relatingto foodstuffs intended for particular nutritional uses can be found specially prepared for people intolerant to gluten making either ‘gluten-free’ or ‘very low gluten’ claims must benotified to the relevant authority when placed on the market for the first time. This is because of an EC obligation tomonitor the market. It is therefore the responsibility of the manufacturer, or in the case of imported foods, the importer,to notify the relevant authority whenever products are marketed in one or more Member States. Notification is requiredin each country in which the product is marketed.• General Labelling (Including Allergen Labelling):Regulation (EU) 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision offood information to consumers: allergen labelling rules continue to apply alongside rules for ‘gluten free’ claims. These rules require productscontaining gluten-containing cereals to make this clear on the label. This may be in the ingredients listing or, in theabsence of a list of ingredients, in a statement prefixed by the word ‘contains’.p // 82
  • 83. Figure 1: How to label your product if you would like to make a claim about its suitability for people intolerant to gluten STEP 1 Is your product a Parnuts food, which has been specially prepared to meet the dietary needs of people intolerant to gluten and marketed a such? STEP 2 Does your product STEP 2B contain 20mg/kg or Does your product less either through YES NO contain 20mg/kg substitution of a or less gluten? gluten-containing ingredient and/or use of a gluten-reduced ingredient? STEP 3 YES NO Does your product contain 100mg/kg You may label your YES NO You should label your Your product cannot be or less gluten and product “gluten free” labelled “gluten free” product “gluten free” contain a No claim can be made gluten-reduced about its suitability for ingredient? people with coeliac disease Your product cannot YES NO be labelled “gluten You should label your free” or “very low product “very low gluten” gluten” No claim can be made about its suitability for people with coeliac disease4 ‘Normal Foods’ or ‘foods for normal consumption’ have not been processed, manufactured or prepared in a way to meet thespecific needs of people with a particular nutritional requirement, e.g. malt vinegar, a cereal bar that is traditionally made withpuffed rice.p // 83
  • 84. 3. Review European PARNUTS Legislationa) General b) Rules Covering Gluten-Free LabellingThe European institutions, on the basis of a proposal The initial Commission proposal suggested that thesubmitted by the Commission as part of its on-going existing gluten-free foods governed by Regulationprogramme of simplification and reducing legislative (EC) 41/2009 move under the general food law with noburden, are reviewing the current Framework Directive special provisions.on PARNUT foods (Directive 2009/39/EC). Following intensive discussions around this issue,This proposal for a Regulation5 on ‘food intended for the European institutions ultimately decided to moveinfants and young children and on food for special the provisions of Regulation 41/2009 into the revisedmedical purposes’ repeals the provisions of Directive Food Information to Consumers Regulation, taking into2009/39/EC (the majority of the provisions laid down account that coeliacs are vulnerable consumers whodate back to 1977) and intends to address the difficulty require more specific provisions.experienced by consumers in making an informedchoice between dietetic foods, fortified foods, foods A specific recital has been included in the lastbearing claims and foods for normal consumption. The compromise text ensuring the future labellingproposal abolishes the concept of ‘dietetic foods’ for the differentiation between specially formulated gluten freebenefit of the expression ‘specialised nutrition’. products and those for general consumption, via the adoption of delegated and implementing acts.The adoption and entry into force of updated Europeanlegislations as, inter alia, Regulation 1924/2006 onnutrition and health claims made on foods, Regulation1925/2006 on the addition of vitamins and minerals andother substances to food and Regulation 1169/2011on the provision of food information to consumers, is aadditional factor making necessary the thorough reviewof Directive 2009/39/EC.5 European Commission Proposal for a Regulation on Food Intended for Infants and Young Children and on Food for SpecialMedical Purposes (June 2011): // 84
  • 85. Avenue des Nerviens 9-31, 6th floor1040 BrusselsBELGIUMtel: 32 2 514 11 11fax : 32 2 511 29 05e-mail: info@fooddrinkeurope.euwebsite: