Get a Handle on Allergens

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.

References

1. 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.
2. 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.
3. 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.
4. Allergy Advisor. Lentils. Available at: www.allallergy.net/fapaidfind.cfm?cdeoc=863. Accessed July 6, 2011.
5. 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.
6. 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.
7. U.S. Food and Drug Administration. Allergy Inspection Guide. FDA. Available at: www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074944.htm. Accessed July 6, 2011.