Components Of An Effective Allergen Control Plan
Components of an EffectiveAllergen Control PlanA FRAMEWORK FOR FOOD PROCESSORS
An Allergen Control Plan protects consumers —and your company.When a food safety issue due to mishandling of allergenic ingredients occurs, everyone in the foodprocessing industry suffers. Consumers depend on food companies to provide safe products. Consumers whomust be mindful of the foods they eat because of potential allergic reactions are especially dependent on theindustry’s ability to identify, process, and market foods which are labeled correctly.Food-allergic consumers must avoid the foods that trigger their allergic reactions. Thus, they rely heavily uponthe ingredient statements of packaged food products to identify the products which contain their allergen(s).Labeling of foods for the presence of allergenic foods must identify all foods that intentionally contain theparticular food or ingredients derived from that food. However, voluntary labeling for the possible presence ofthe allergen (e.g. ‘may contain x’) should be reserved for situations that potentially represent genuine hazards.In recent years, there has been a proliferation of the use of precautionary allergen statements, which rangein wording from “May Contain” and “Processed in a Facility”, to “Made on Shared Equipment”. This increasehas limited consumer food choices. Alarmingly, food-allergic consumers, especially teens, are beginning toignore precautionary statements, and taking risks regarding the food they choose to eat. This can lead totrouble for both the consumer and the industry.An Allergen Control Plan is a critical component in your product safety initiatives. You must do everythingwithin your power to ensure allergenic foods and ingredients do not find their way into products for whichthey are not intended. Your Allergen Control Plan is your company’s written document regarding the storage,handling, processing, packaging, and identification of allergenic foods and ingredients.This is not a one-time effort. Your Allergen Control Plan must be implemented, audited, enforced and updatedcontinually. Every time you make a change in a process or a product, assess your plan and update as needed.Every time you hire a new employee or change the responsibilities of an employee, make certain theyunderstand their role in the Allergen Control Plan through documented training. Every time you begin workingwith a new supplier, evaluate their Allergen Control plan and change yours as needed. If you change or addlocations, a new Allergen Control Plan should be developed specifically for that location.This document is not intended to be comprehensive by any means. The intent is to provide food processingcompanies with a framework for an Allergen Control Plan — and an introduction to the issues andconsiderations which are typically included in such a plan.Not all recommendations are applicable to all food processing companies. Still, it is important to considereach recommendation and determine the extent to which it may apply to you or your suppliers — and thencreate the appropriate procedures in the Allergen Control Plan that will help your plant.An Allergen Control Plan is about protecting the health and confidence of consumers. But it is also aboutprotecting the financial health and reputation of your company.We hope this document is valuable to you and your team as you create the Allergen Control Plan for your company.
The FundamentalsR E C O M M E N D AT I O N SThe first step in developingyour Allergen Control Planis to identify key leadersin your organization whonot only understand howingredients flow through yourfacility, but also understandthe vital importance of Form an allergen control team in your company consisting ofrepresentatives from all appropriate departments. This mayinclude, but not be limited to:- Manufacturing- Quality- Labeling/Regulatory Compliance- Research and Development- Engineering- Sanitation- Food SafetyNote: Smaller companies may not have all of thesedepartments, so select a cross-section of expertise asappropriate to your operation.managing and controllingthese ingredients at everystage from choosing suppliersto handling, storage,processing, packagingand labeling — every day. Conduct a risk assessment to determine the choice ofspecific allergen management procedures. Develop an allergen process flow diagram — or “allergenmap” — to understand where allergenic ingredients andfoods exist in the plant and where they are introduced intothe process. Develop an Allergen Control Plan specific to eachprocessing facility. Review the Allergen Control Plan regularly and update whennecessary — especially when new ingredients are added,when processes or protocols are changed, or when newproducts or equipment are introduced into the plant.
Product Design (Research and Development)R E C O M M E N D AT I O N SAllergen management beginswith new product concepts,research and developmentproduct prototypes,new ingredients, and newlabels. The followingrecommendations shouldhelp guide your innovation. Only add allergens to new products when they makea discernable difference in the taste or functionalityof the product. Question ingredient suppliers on the functionality andnecessity of allergens in their formulation. Understand the existing allergens or lack of allergens in themanufacturing facilities when formulating new products. Create a process to review allergens in new products withthe manufacturing facility prior to ordering ingredients andstart up. Avoid using allergenic ingredients in such low amounts thatthey have no or minimal functional effect in the finished product.
Segregation of Allergenic Foods or IngredientsDuring Receiving, Storage, Handling and ProcessingR E C O M M E N D AT I O N SAn effective Allergen ControlPlan depends on keepingallergenic foods andingredients separate fromall other products andingredients from the timethey enter your facility untilthey are introduced into theproduction line and beyond.Every attempt must be madeto visibly identify allergensand isolate them — at everystep — from other foods,ingredients and equipment.Receiving Review the labels of incoming raw materials for theappropriate allergen information or any changes. Tag each case/pallet/bag, etc. as appropriate of rawmaterials to ensure the allergen is clearly called out as thematerials are stored and used in your facility. Companies maywant to use color coding, tagging, or other means to identifythe allergenic ingredients. Handle appropriately any damaged containers of allergensto minimize cross-contact at receipt.Storage Store allergenic ingredients or products separately toprevent cross-contact. Protocols may include:- Using clean and closed containers- Designating separate storage areas for allergenic andnon-allergenic ingredients and/or products. Whensegregated storage is not possible, use other methodssuch as not storing allergens over non-allergens, storinglike allergens (milk and whey) together, etc.- Using and documenting clean up procedures for spillsor damaged containers of allergens- Using dedicated pallets and bins- Using clearly designated staging areas for allergenicfoods and ingredients Identify allergenic ingredients by a mark or tag (or color code) —and isolate allergens from non-allergenic ingredients/products in storage.
Supplier Control Programsfor Ingredients and LabelsR E C O M M E N D AT I O N SWhat comes into your facility Require your ingredient suppliers to have a documentedAllergen Control Plan.from suppliers has an equallyimportant impact on thequality and integrity of yourfood processing protocols —and ultimately your legalexposure as well. YourAllergen Control Plan shouldalso outline expectations,documentation and validationto ensure your suppliersare diligent and equally asdedicated to controlling andmanaging allergens. Require letters from suppliers that guarantee the ingredientsyou purchase do not contain undeclared allergens. Require your suppliers to notify you of any changes tothe allergen status of the ingredients they supply priorto any changes. Audit your suppliers on a regular basis to assess theeffectiveness of their Allergen Control Plan. Require suppliers to have sanitation cleaning procedures inplace which are validated on a regular basis and wheneverthere is a change that may affect the allergen status of theline (i.e. new or changed product, ingredient, equipment, etc.). Conduct a supplier survey which includes the following:- The Allergen Control Plan of the supplier- The range of allergenic products produced by the supplier,especially on shared equipment with your ingredient(s)- The supplier’s allergen cleaning program and protocols- Allergen training records for supplier’s employees Ensure allergenic ingredients are shipped in clearlymarked, sealed containers — and the containers are notdamaged or broken.
Prevention of Cross-Contact During ProcessingR E C O M M E N D AT I O N SThe very act of processingincludes a number ofopportunities and risks forallergenic ingredients to beintroduced into the wrongfood product. Human errorin formulation is only onerisk factor. Intelligent productscheduling and dedicatedequipment and processinglines can go a long way towardpreventing contamination.It is important to considerfactors such as whenallergenic ingredients areintroduced into the process —and traffic which couldinadvertently carry allergensfrom one point in the facilityto another.Scheduling of processing runs Schedule long runs of products containing allergenicingredients in order to minimize changeovers. Segregate production areas for allergenic and non-allergenicproducts. If this is not possible, schedule manufacturing ofnon-allergenic foods before processing foods with allergens. Schedule sanitation immediately after production of foodscontaining allergenic ingredients. When product design permits, add allergenic ingredients aslate in the process as possible.During manufacture Ensure the traffic patterns of raw materials, packaging supplies,and employees are limited during the manufacture of allergencontaining products and do not lead to cross-contact. If possible, have dedicated processing equipment and linesto prevent allergen cross-contact. Whenever possible, make products with similar allergens onthe same equipment. For production lines with crossover points, prevent allergenicfoods from falling onto non-allergenic production lines. When processing lines are in close proximity, minimize theallergen risk by adding physical barriers to separateallergenic and non-allergenic production lines. Dedicate tools, containers and utensils — and clearly markthem or use a color code to identify allergenic ingredientand/or product. When dedicated utensils and equipment arenot possible, the items must be cleaned prior to using in themanufacture of non-allergenic products. Minimize the reuse of processing and/or cooking media suchas water or oil. If cooking media is reused, test to validatethere is no cross-contact for non-allergen products. Restrict personnel working on processing lines containingallergenic ingredients from working on non-allergenicproduction lines. Visually identify which employees areworking on a line that contains allergens (different coloreduniform, hair net, etc.). When products containing allergens are being manufactured,ensure allergens are identified throughout the processincluding visually tagging or color coding equipment.
Prevention of Cross-Contact During Processing.continuedControl of rework and work in process Use color-coded tags to identify and record:- When reworked products with allergenic ingredientsare produced- Where these products are stored- The products into which they are reworked- When these products are added back into the lineand how much is used Use rework containing unique allergenic foods and/oringredients only in the same formulation (a “like into like”or “exact into exact” practice, for example).Maintenance and engineering Purchase and design equipment using sanitary design principles. Maintain equipment to ensure systems are operatingas designed. Design traffic patterns and airflow in the production facilityto prevent allergen cross-contact. Ensure equipment is positioned for easy access to cleanand inspect. Assure maintenance procedures for working on processing lineseliminate cross-contact to non-allergen containing products –both during operations and during preventive maintenance. Determine the need to separate allergenic and non-allergenicproduction lines with physical barriers, separate employees,or other methods to prevent cross-contact. For production lines with crossover points (conveyor belts, etc.),prevent allergenic foods from falling onto non-allergenicproduction lines. Assess the risk of migration of allergenic dust to non-allergenproduct lines during processing .
Product Label Review & Label/PackagingUsage and ControlR E C O M M E N D AT I O N SThe only way consumersknow of potential allergensin your product is to read thelabel or packaging. They areplacing their trust — and insome cases, their very healthand lives — in your hands.Proper packaging labels notonly help protect yourconsumers, but protect yourcompany from costly recalls, Ensure packaged foods regulated under the Federal Food,Drug and Cosmetic Act, comply with the Food AllergenLabeling and Consumer Protection Act of 2004. For theserequirements, visit www.cfsan.fda.gov/ dms/alrgact.html. It is important to know companies cannot arbitrarily add“may contain” or other precautionary labeling because in1996, FDA advised that “because adhering to goodmanufacturing practice (GMP) is essential for effectivereduction of adverse reactions, precautionary labelingshould not be used in lieu of adherence to GMP.”(http://www.cfsan.fda.gov/ lrd/allerg7.html) Ensure packaged foods regulated under the Federal Meat &Poultry Act comply with the Food Allergen Labeling andConsumer Protection Act of 2004. Additionally, USDArequires that meat and poultry plants reassess their HACCPplans and prerequisite programs to address ubs/05-016N.htm)regulatory scrutiny, andpotential liability. Ensure label approval processes are in place for new productsor changes to current products. Review incoming labels prior to receipt for accuracy. Ensure product specification and formulation changes areimmediately reflected on labels. Consider approaches tohighlight newly introduced allergen components. Monitor, document, and verify the correct label at allchangeovers as they occur. Discard all out-of-date labels or packaging in a timely manner. Implement proper inventory control procedures forpackaging materials. Implement proper packaging staging control procedures. Train line personnel on techniques for ensuring productlabels are switched appropriately at product changeover onthe production line.
Validated Allergen Cleaning ProgramR E C O M M E N D AT I O N SIt doesn’t matter what thecause — leftover ingredientsin a hard-to-reach corner ofyour processing line, a halfhearted cleaning effort dueto employee fatigue or alooming product deadline —any allergen residue notadequately cleaned andremoved from yourprocessing line can find itsway into the next product onthe line, causing your nextproduct to inadvertentlycontain an allergen notincluded on the label —and that can have graveconsequences. It’s a matter ofprocess design, protocoldocumentation and thoroughvalidation of cleaningprocedures — and yourAllergen Control Plan needsto account for it all.Overall plant design Construct processing equipment and overall plant structurewith good sanitary features including:– Ease of cleaning and sanitizing– No “dead spots” that allow accumulation of food oringredients (no hollow rollers, no holes in welds,equipment that drains, etc.)– Accessibility of equipment for visual inspectionSanitation standard operating procedures Protocols should be clearly written and easy to followand understand. Define the scope of the cleaning procedures—range ofapplications, equipment, products, etc. Define who is responsible for the cleaning operations. Include detailed cleaning instructions.– Documented training should occur on a regular frequencyCleaning validation procedures Protocols should be clearly written and easy to followand understand. Define the intention and scope of validation. Describe the sampling procedures and the reason forconducting them. Define and describe the analytical procedures to be used. Define the final acceptance/validation criteria. Ensure all associated product is held pending test results.Cleaning verification procedures Protocols should be clearly written and easy to followand understand. Define the intention and scope of verification procedures. Describe the sampling procedures and the reason forconducting them. Define and describe the analytical procedures to be used. Define the final acceptance/verification criteria.Confirmation and compliance Validate the analytical procedures used to verify and validatecleaning efficacy. Keep detailed records for cleaning, validation and verification. Evaluate the allergen cleaning program periodically foreffectiveness and compliance. Monitor and verify the Allergen Control Plan frequently withinternal and/or external audits.
Staff Training and EducationR E C O M M E N D AT I O N SUltimately, the effectiveness Provide general training on allergen awareness and controlfor all employees at all levels of the company.of your Allergen Control Plancomes down to people:trained employees andmanagers can be yourgreatest asset. You wantemployees who not onlyunderstand what to do,when to do it and how to doit — but more importantly,why it needs to be done toprotect your company andthe consumers who trustyour products. Training isessential and needs to bean ongoing commitment,for both new andexperienced employees. Provide specific documented training to employees asdictated by their job responsibilities. In all training, include information on the reasons protocolsare required—as well as the potential consequences shouldthe plan not be followed.
Allergen Precautionary Labeling:Food Manufacturers’ Frequently Asked Questions1. What is the Food Allergen Labeling and ConsumerProtection Act (FALCPA)?FALCPA is a law that went into effect on January 1,2006. It requires that food labels identify the sourceof all major allergens in the food’s ingredient list insimple language. Unless the food source of a majorfood allergen is part of the ingredient’s common andusual name (e.g. milk, wheat), it must be labeled inone of two ways. It may be added in parenthesis afterthe ingredient (e.g. whey (milk), flour (wheat)) or canbe identified at the end of the ingredient list in a“contains” statement (e.g. contains milk and wheat).2. What are the major food allergens in the US?Worldwide?FALCPA identifies eight foods or food groups as themajor allergens. They are milk, eggs, fish, crustaceanshellfish (e.g. shrimp, crab, lobster), tree nuts (e.g.almonds, walnuts, pecans, etc.), peanuts, wheatand soybeans. On a worldwide basis, the CodexAlimentarius Commission has established a list ofcommon Allergenic Foods. Specific countries havetheir own distinct lists of common allergenic foods.A compilation of the lists of various countries isavailable at www.farrp.org .3. What is cross-contact?Cross-contact occurs when a residue or traceamount of an allergen unintentionally crosses overinto a product that doesn’t have that allergen. Suchoccurrences are sporadic.4. How does cross-contact occur?Cross-contact (the inadvertent introduction of anallergen into a product) is generally the result ofenvironmental exposure during food processing orhandling. Cross-contact occurs when multiple foodsare manufactured on the same processing line,through the misuse of rework, as a result
Review the labels of incoming raw materials for the appropriate allergen information or any changes. Tag each case/pallet/bag, etc. as appropriate of raw materials to ensure the allergen is clearly called out as the materials are stored and used in your facility. Companies may want
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www.hygiena.com 2 ALG-WP-3005-REVA White Paper Food Allergen Declaration, manufacturers and processors are required to identify Global Requirements In the United States, the FDA Food Allergen Labeling and Consumer Protection Act, 21 U.S.C. 2004 (FALCPA)5 identified the eight major food allergens which account for more than 90% of allergic reactions.
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3. Allergen Risk Assessment, Management and Communication 10 3.1 Allergen Risk Assessment 10 3.2 Allergen Risk Management 14 3.2.1 General Principles 14 3.2.2 Manufacturing 14 People 15 Raw Materials and Supply Chain 16 Manufacturing Premises, Equipment and Processes 18 Cleaning 20 Packaging 21 New Product Development and Reformulation 21
Allergy, Asthma & Immunology (AAAAI); the American Col-lege of Allergy, Asthma & Immunology (ACAAI); and the Joint Council of Allergy, Asthma & Immunology (JCAAI). The objective of ‘‘Allergen immunotherapy: a practice param-eter third update’’ is to optimize the practice of allergen immu-notherapy for patients with allergic diseases.
there are questions to answer and diagrams to label. Marieb (2007) is the core anatomy and physiology text used, which corresponds to local undergraduate pre-registration and learning beyond registration curriculum’s at the University of Southampton. A recommended reading list is provided.
