Guidance on Food Allergen Management               for Food ManufacturersJanuary 2013
Index         Foreword ....................................................................................	p. 03         ...
Foreword                                                      Jesús Serafín Pérez                                         ...
IntroductionThis Guidance document was prepared by FoodDrinkEurope to provide sound, evidence-basedand consistent informat...
Scope                                                          	                                                          ...
Risk Management 		                                                Processes2.1	OverviewThe need to manage potential risks ...
Changes to any process within a food production            will therefore require a re-assessment of the originalfacility,...
2.2 	People2.2.1	Training                                                              General allergen awareness includin...
2.2.2 Personal HygieneCross-contact of products with               Contractors and visitors mustallergenic materials may o...
2.3	 Supplier ManagementA food operator at any point in the supply chain can           Understand the allergen risk analys...
2.4	 Raw Materials Handling2.4.1 Incoming Raw Materials Handling                          2.4.2 Handling of Raw Materials ...
2.5	 Equipment and Factory DesignProduction includes ingredient dispensing, recipe             Movement Control:make-up, m...
2.6 	Production Process and Manufacturing Controls2.6.1 Recipe Verification                                    2.6.3 Inter...
It is important that, following recipe changes or the        2.6.5	 Rework – Internally Recycled Productintroduction of a ...
2.7 	Consumer Information2.7.1 Ingredient Labelling                                   2.7.2 Non-commercial Samples        ...
2.8 	Product Development and Change2.8.1 Reformulating Products                                   should be mindful of the...
2.9	 Documentation and Record-KeepingEfficient and accurate record keeping is critical to the   A record of the risk manag...
Cleaning and                                                Cleaning Validation3.1	GeneralEffective cleaning is one of the...
Consideration should be given to maintenance activities,such as the use of dedicated tools or adequate cleaningprocedures ...
3.2 Cleaning Methods3.2.1 	 Wet Cleaning                                        material addition points, internal hoppers...
It is recommended that the validation be carried by       A validation study requires the physical validation ofa multi-sk...
Analytical                                                Methods and their                                               ...
Analytical results are very useful when the effectivenessof cleaning procedures (cleaning validation) needsto be assessed....
Key Principles                                               of Allergen Risk                                             ...
• Manufacturing                                       • Communication          Handle incoming raw materials and          ...
Glossary of TermsAllergen                                    of the “allergen status” of materials      whether the correc...
Food additive                            carrying out any of the activities                lactose     intolerance     is ...
Good Manufacturing Practice                 Hazard                                          is capable of binding to that(...
Labelling                                   Management reviews are also used        Packaging                             ...
Processing aid                              Risk                                    Senior / Top managementAny substance w...
p // 31
Annex 1               Background on Food               Allergies and Intolerancesp // 32
Introduction                                                   What is a food allergy?Food allergies affect around 2 to 4%...
Allergic reactions to food can vary from very slight tosevere and occasionally fatal, depending on the dose,              ...
How Much is Too Much?The range of minimum doses required to provoke a            doses in the allergic population for some...
FoodDrinkEurope: Guía sobre la Gestión de Alérgenos en la industria alimentaria
FoodDrinkEurope: Guía sobre la Gestión de Alérgenos en la industria alimentaria
FoodDrinkEurope: Guía sobre la Gestión de Alérgenos en la industria alimentaria
FoodDrinkEurope: Guía sobre la Gestión de Alérgenos en la industria alimentaria
FoodDrinkEurope: Guía sobre la Gestión de Alérgenos en la industria alimentaria
FoodDrinkEurope: Guía sobre la Gestión de Alérgenos en la industria alimentaria
FoodDrinkEurope: Guía sobre la Gestión de Alérgenos en la industria alimentaria
FoodDrinkEurope: Guía sobre la Gestión de Alérgenos en la industria alimentaria
FoodDrinkEurope: Guía sobre la Gestión de Alérgenos en la industria alimentaria
FoodDrinkEurope: Guía sobre la Gestión de Alérgenos en la industria alimentaria
FoodDrinkEurope: Guía sobre la Gestión de Alérgenos en la industria alimentaria
FoodDrinkEurope: Guía sobre la Gestión de Alérgenos en la industria alimentaria
FoodDrinkEurope: Guía sobre la Gestión de Alérgenos en la industria alimentaria
FoodDrinkEurope: Guía sobre la Gestión de Alérgenos en la industria alimentaria
FoodDrinkEurope: Guía sobre la Gestión de Alérgenos en la industria alimentaria
FoodDrinkEurope: Guía sobre la Gestión de Alérgenos en la industria alimentaria
FoodDrinkEurope: Guía sobre la Gestión de Alérgenos en la industria alimentaria
FoodDrinkEurope: Guía sobre la Gestión de Alérgenos en la industria alimentaria
FoodDrinkEurope: Guía sobre la Gestión de Alérgenos en la industria alimentaria
FoodDrinkEurope: Guía sobre la Gestión de Alérgenos en la industria alimentaria
FoodDrinkEurope: Guía sobre la Gestión de Alérgenos en la industria alimentaria
FoodDrinkEurope: Guía sobre la Gestión de Alérgenos en la industria alimentaria
FoodDrinkEurope: Guía sobre la Gestión de Alérgenos en la industria alimentaria
FoodDrinkEurope: Guía sobre la Gestión de Alérgenos en la industria alimentaria
FoodDrinkEurope: Guía sobre la Gestión de Alérgenos en la industria alimentaria
FoodDrinkEurope: Guía sobre la Gestión de Alérgenos en la industria alimentaria
FoodDrinkEurope: Guía sobre la Gestión de Alérgenos en la industria alimentaria
FoodDrinkEurope: Guía sobre la Gestión de Alérgenos en la industria alimentaria
FoodDrinkEurope: Guía sobre la Gestión de Alérgenos en la industria alimentaria
FoodDrinkEurope: Guía sobre la Gestión de Alérgenos en la industria alimentaria
FoodDrinkEurope: Guía sobre la Gestión de Alérgenos en la industria alimentaria
FoodDrinkEurope: Guía sobre la Gestión de Alérgenos en la industria alimentaria
FoodDrinkEurope: Guía sobre la Gestión de Alérgenos en la industria alimentaria
FoodDrinkEurope: Guía sobre la Gestión de Alérgenos en la industria alimentaria
FoodDrinkEurope: Guía sobre la Gestión de Alérgenos en la industria alimentaria
FoodDrinkEurope: Guía sobre la Gestión de Alérgenos en la industria alimentaria
FoodDrinkEurope: Guía sobre la Gestión de Alérgenos en la industria alimentaria
FoodDrinkEurope: Guía sobre la Gestión de Alérgenos en la industria alimentaria
FoodDrinkEurope: Guía sobre la Gestión de Alérgenos en la industria alimentaria
FoodDrinkEurope: Guía sobre la Gestión de Alérgenos en la industria alimentaria
FoodDrinkEurope: Guía sobre la Gestión de Alérgenos en la industria alimentaria
FoodDrinkEurope: Guía sobre la Gestión de Alérgenos en la industria alimentaria
FoodDrinkEurope: Guía sobre la Gestión de Alérgenos en la industria alimentaria
FoodDrinkEurope: Guía sobre la Gestión de Alérgenos en la industria alimentaria
FoodDrinkEurope: Guía sobre la Gestión de Alérgenos en la industria alimentaria
FoodDrinkEurope: Guía sobre la Gestión de Alérgenos en la industria alimentaria
FoodDrinkEurope: Guía sobre la Gestión de Alérgenos en la industria alimentaria
FoodDrinkEurope: Guía sobre la Gestión de Alérgenos en la industria alimentaria
FoodDrinkEurope: Guía sobre la Gestión de Alérgenos en la industria alimentaria
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

  1. 1. Guidance on Food Allergen Management for Food ManufacturersJanuary 2013
  2. 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. 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. 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. 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. 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 foods.safety, quality and legal requirements, using appropriatemanufacturing operations controls, including effective Cleaning of premises, equipment and tools.food 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 used.management, 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. 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. 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. 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. 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 i.e.management. 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. 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 floor.contact 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. 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. 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. 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. 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. 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 testing.an 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. 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. 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 appropriate.as 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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 presence.management system. It is usedto identify, prevent, and control Classes of immunoglobulin.food 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. 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. 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 options.catering, 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. 31. p // 31
  32. 32. Annex 1 Background on Food Allergies and Intolerancesp // 32
  33. 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. 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. 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

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