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Get a Handle on Allergens
A range of detailed regulations outlines proper procedures to combat the most prevalent culprits
by James Cook
More than 160 foods can cause allergic reactions, and it is estimated that 5 million to 12 million Americans suffer from food allergies. This corresponds to 4% to 8% of children and 1% to 3% of adults. An allergic reaction to food occurs when a person’s immune system attacks a food substance, usually a protein. The U.S. Food and Drug Administration (FDA) estimates that 30,000 emergency room visits, 2,000 hospitalizations, and 150 deaths occur from food-related anaphylaxis annually.1 At present there is no cure for food allergies, so strict avoidance is the only way for a consumer to avoid an allergic reaction.
In order to help American consumers avoid the eight major allergens listed by the FDA, Congress passed the Food Allergen Labeling and Consumer Protection Act in 2004 (Public Law 108-282, Title II).2 This law, which mostly amends sections 403 and 201 of the Federal Food Drug and Cosmetic Act of 1938, became effective Jan. 1, 2006. The law requires labeling of the eight major allergens, which together cause 90% of allergic reactions to food in the U.S. The major allergens are crustacean shellfish, eggs, fish, milk, peanuts, soy, tree nuts, and wheat.
In the U.S., some of these allergens have been specifically defined. Milk in the U.S. is an ingredient derived from cows, as per the 21 Code of Federal Regulations (CFR), section 131.10. The Egg Products Inspection Act defines an egg as a shell egg of a domesticated chicken, turkey, duck, goose, or guinea fowl. The FDA defines crustacean shellfish as crabs, crayfish, lobsters, or shrimps. Tree nuts are defined by the FDA in a list that includes almond, beech nut, Brazil nut, butternut, cashew, chestnut, coconut, filbert (hazelnut), ginko nut, hickory nut, lichee nut, macadamia (bush nut), pecan, pine nut (piñon), pistachio, shea nut, and walnut. The FDA defines wheat as common wheat, durum wheat, club wheat, spelt, semolina, Einkorn, emmer, kamut, and triticale.
Outside the U.S.
In the U.S., ingredients like gluten, sulfites, and yellow No. 5 are not considered allergens but rather as sensitizing or intolerant ingredients and have their own specific labeling requirements. In other countries, different food items are recognized as allergens. In the European Union, the eight major allergens listed by the FDA are regarded as allergens, along with celery, mustard, sesame seeds, lupin, mollusks (e.g., clams and oysters), and sulfites.3
Some allergens, such as lentils—the fourth most common cause of allergic reactions in Spanish children and the fifth leading food allergen in India—can cause reactions that range from mild to severe.4 As more people from countries that use lentils in their diets settle in the U.S., this food allergy is seen more frequently. Rice, a common allergen in countries in which it is a staple food, is a less common allergen in the U.S., although the incidence of rice allergy is rising along with the increase in its consumption. Corn can trigger an allergic reaction, but the reactions are usually mild, though there have been cases of anaphylaxis related to corn and corn products.
The American Academy of Pediatrics (AAP) recently published a study that lists the frequency with which common allergens appear in children: 2% for peanut, 1.7% for milk, 1% for tree nuts, 0.8% for eggs, 0.5% for fin fish, 0.4% for strawberries, 0.4% for wheat, and 0.4% for soy.5 This research shows that, other than the inclusion of strawberries rather than crustaceans, the AAP’s list is in line with the FDA’s top eight allergens. Shellfish replace strawberries on the FDA list because 2% of adults are estimated to be allergic to shellfish.
U.S. law requires allergens to be listed on the packaging in one of two ways. The first method of labeling for allergens is a “contains” statement that immediately follows the ingredient list. The second method lists the allergen in parentheses immediately after the actual ingredient that contains the allergen, except when the name in the ingredient list specifies the allergen or when the allergen is already listed in the ingredient statement. For allergens from tree nuts, fish, and crustacean shellfish, the type or species of the allergen must be listed as part of the allergen declaration. Additionally, the law requires all ingredients that are derived from the allergen, including spices, flavorings, colorings, and incidental food additives, to comply with these regulations.
Exceptions to the law are highly refined oil derived from an allergen or a food ingredient that, although it is derived from an allergen, has proved by petition to and approval of the FDA to contain no allergen protein. Some ingredients exempted from the allergen labeling law are hydrogenated soybean oil and modified food starch.
It appears that every day there is yet another recall of a food product because of an undeclared allergen. In the Reportable Food Registry’s annual report, the FDA noted that 69 of the 229 (30.1%) food safety entries were for undeclared allergens.6 Including other intolerances (undeclared sulfites) brings the total to 80 reports, 34.9% of the food safety entries. Bakery products were identified in 17.5% of the undeclared allergen intolerance reports, and a milk allergen was identified in 29% of the reports.
So what is a supplier, manufacturer, or retailer supposed to do? Should a supplier list all the allergens possible under a “may contain” statement? While the FDA and the U.S. Department of Agriculture do not prohibit the use of such advisory statements, the agency does acknowledge that this practice should be reserved for those situations when the allergen may still be in the product, even if good manufacturing practices and other industry best practices are followed. Both agencies believe the indiscriminate use of “may contain” statements does not help those who are allergic to spot specific allergens and that these statements should only be used when all other methods have been tried and have failed.
The FDA Guide
In 2001, the FDA developed its inspection guide, giving the industry insights into what areas to address in an allergen control program.7 The agency broke the inspection into the following areas: product development, receiving, equipment, processing, finished product testing, and labeling. The list of areas to investigate should help any firm, big or small, to develop an allergen control program. The methods can apply to any product.
In product development, a company must identify the sources of allergens in the product. Are all ingredients and sub-ingredients for the product identified? For ingredients such as vitamins, spices, flavorings, and colors, are any carriers allergens? Does your product contain juice clarified using isinglass, a fish allergen? Are there going to be any processing aids or rework? Will there be any dust or potential transfer of ingredients from one line to the next? What else is being made on the product line of this new item? Does the packaging material have any releasing agent that could be a food allergen (for example, foil with wheat-releasing agent)?
In the Reportable Food Registry’s first annual report, the FDA noted that 69 of the 229 (30.1%) food safety entries were for undeclared allergens. Including other intolerances (undeclared sulfites) brings the total to 80 reports, 34.9% of the food safety entries.
Receiving: It is necessary to separate raw materials that are allergens from other materials. They must be properly identified and stored separately to prevent cross-contamination. If bulk tanks are used, are they only used for one material, or are they cleaned out and used to store other materials? What does the raw material declare as allergens, and is there a “may contain” statement on its label? How will the raw material label information be transferred to the information on the finished good? How often is this checked and verified?
Equipment: Are there any places in the equipment that can trap allergens? Make sure you have equipment that is easily cleaned. Because most companies do not have the luxury of brand new and easy-to-clean equipment, check for build-up in corners, dents, cracks, or welds and be sure that conveyors are in good repair and easily cleanable. Is the cleaning process verified and validated to remove the product and/or allergens? While cleaning should always be reviewed visually and microbiologically, it is also necessary to assess the removal of allergens. There are methods available that can be used to determine the presence of a protein or allergen, allowing companies to be sure that the lines are clean.
Processing: Control measures must be in place to prevent cross-contamination and improper labeling. These must be performed at the point where they actually can control and prevent. If non-allergen items are run on the line with allergen items, the non-allergen items must either be run first or after a thorough cleanup and a verification that the cleanup has removed the allergens. During processing, all materials must be properly identified and traced.
Packaging: All ingredients and materials need to be identified and traced. A verification of change of ingredients on the packaging must be made. Raw material ingredients must be verified on a routine basis and compared to those listed on the finished product. A system must be established to make sure the product is placed in the correct packaging. Packaging brought to the product line must be verified as the correct packaging, and the product that is going into it must be verified as the correct item. If the packaging is returned to inventory, it must be placed with the correct packaging. All old packaging that does not conform to the current ingredient information must be disposed of immediately.
It is best to establish the flow of all ingredients from receiving to shipping, so that not only the process flow but the entire flow of materials is being checked for potential cross-contamination. Separation of a non-allergen product line from the personnel and equipment working on an allergen product line is the best approach. If this separation cannot be achieved, eliminating potential cross-contamination is absolutely necessary.
Finished product testing: There are two methods for testing: enzyme-linked immunosorbent assay (ELISA) and polymerase chain reaction (PCR). If performing your own testing, make sure that the testing method has been recognized by a standards organization or government agency and that the methodology has been validated internally. If using an external third-party laboratory, make sure it uses a testing methodology recognized by a standards organization or government agency and that the method has been validated in that laboratory. The results of the method must allow you to obtain the level of detection needed. Make sure the method is best suited for the finished product being tested. ELISA testing methods do not work properly with heat-treated products, hydrolyzed proteins, probiotic cultures, fermented products, and under certain other conditions.
For all areas of operations, the most important factor is to train all employees in the allergen control program. Most companies devise great programs but fail to train and supervise their personnel to ensure that these programs are being properly implemented.
With 160 food products that can create an allergic reaction, it is hard to produce any item that someone in the world is not allergic to. We must be sure that all ingredients are properly declared on the packaging and prevent undeclared ingredients from contaminating the product.
James Cook has been working with SGS since 2009 handling food and food contact technical issues for the Consumer Testing Services group. He has more than 25 years’ quality assurance and technical experience in the food retailing, manufacturing, and private brand brokerage business.
- U.S. Food and Drug Administration. Food allergies: what you need to know. FDA. Available at: www.fda.gov/Food/ResourcesForYou/Consumers/ucm079311.htm. Accessed July 6, 2011.
- U.S. Food and Drug Administration. Food Allergen Labeling and Consumer Protection Act of 2004. FDA. Available at: www.fda.gov/Food/LabelingNutrition/FoodAllergensLabeling/GuidanceComplianceRegulatoryInformation/ucm106187.htm. Accessed July 6, 2011.
- European Union. Official Journal of the European Union Directive 2007/68/EC.EU. Available at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2007:310:0011:0014:EN:PDF. Accessed July 6, 2011.
- Allergy Advisor. Lentils. Available at: www.allallergy.net/fapaidfind.cfm?cdeoc=863. Accessed July 6, 2011.
- The Food Allergy and Anaphylaxis Network (FAAN). Study concludes 8% of children in the U.S. have a food allergy. FAAN website. Available at: www.foodallergy.org/page/study-concludes-8-percent-of-children-in-the-us-have-food-allergy. Accessed July 6, 2011.
- U.S. Food and Drug Administration. FDA Reportable Food Registry: first annual report. FDA. Available at: www.fda.gov/Food/FoodSafety/FoodSafetyPrograms/RFR/ucm200958.htm. Accessed July 6, 2011.
- U.S. Food and Drug Administration. Allergy Inspection Guide. FDA. Available at: www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074944.htm. Accessed July 6, 2011.