Allergens have become an important food safety issue over the past 20+ years and must be addressed by the food industry. Recalls of both FDA and USDA regulated products have seen a dramatic increase since the turn of the Century. The impact of undeclared allergens in foods can result in recalls, monetary losses and most importantly allergic reactions in people resulting in responses ranging from mild symptoms up to anaphylactic shock, possibly resulting in death. In the U.S., it is estimated that approximately 32 million people have food allergies and each year 200,000 people require emergency medical care for allergic reactions to food.1 (Food Allergy Research & Education, Food Allergy Facts and Stats, rev. 2020-06-04)
The goal of this article is to highlight important factors that a food company must consider in order to manage an effective Allergen Control Program (ACP). This article should only be considered the beginning of a program; much research, development and implementation must be undertaken by each company.
It has been reported that more than 170 foods cause reactions to people in the U.S. So, which ones are regulated and for which must a food company develop an ACP? The answer, it depends. In the U.S., per the Food Allergen Labeling and Consumer Protection Act (FALCPA), there are eight (Big 8) foods requiring allergen labeling. Those are: Milk; Egg; Peanut; Tree Nuts (species specific); Fish (species specific); Crustacean shellfish (species specific); Wheat; and Soy.
However, the food manufacturer must be aware of where their products may be sold. Different countries around the world have their own list of specific allergens requiring labeling. As an example, Canada adds mustard, molluscan shellfish, sesame and sulfites > 10 ppm (not a true allergen). Europe adds celery, mustard, molluscan shellfish, sesame, lupin and sulfites > 10ppm.
The University of Nebraska – Lincoln, Food Allergy Research and Resource Program (FARRP) has an International Regulatory Chart for labeling regulations as a reference to better understand the complexities if you are exporting products to other countries.
Whether your company is regulated by the FDA or USDA/FSIS, you should follow proper labeling protocols for the Big 8. Technically, FALCPA only applies to FDA regulated foods. For USDA regulated foods, “FSIS encourages the use of allergen statements, consistent with FALCPA, and other statements that highlight the presence or absence of ingredients of public health concern, particularly the Big 8 allergens.”2 USDA/FSIS, Allergies and Food Safety.
Labeling is not the only regulation for food products. FDA regulated food companies must also address the Preventive Controls for Human Food regulation, which includes food allergen preventive controls to prevent allergen cross contact and to ensure accurate allergen labeling is on finished food products.
Components of an ACP
When sourcing ingredients for food products, food companies must be aware of what allergens may be present in the ingredients they are purchasing. This can be addressed as part of the supplier approval program to ensure suppliers identify and label the allergens present. Supplier approval should also ensure suppliers have an effective ACP in their own operations and that they will communicate when any changes are made to formulations of ingredients that may affect the allergens present.
Receiving and Storage
Ingredients are typically shipped via palletized containers in van trailers or as bulk ingredients in railcars or trailers. For bulk ingredients, it is important that the vehicle is properly cleaned between loads or that the vehicle is dedicated to haul the same ingredient to limit the potential for cross contamination. Inspections of these vehicles should be conducted and documented at the time of receipt. If the vehicle is not dedicated, appropriate cleaning procedures must be in place and Wash Certificates generated to document the cleaning.
When transferring bulk ingredients, care should be taken to ensure unloading equipment (conveyors, hoses, pumps, etc.) are properly cleaned or are dedicated to that specific ingredient to limit the potential for cross-contact between different ingredients and allergens.
When ingredients are received via van trailers, inspection of the vehicles should be conducted at the time of receipt to verify there is not cross contamination from breakage or spillage of ingredients and that if pallets are double stacked in the trailers, allergens are not stacked on top of non-allergen or different allergen food products.
For palletized ingredients, these should be appropriately labeled to clearly indicate the allergens present so that warehouse personnel can determine how and where to stage these items in storage. The “Like Above Like” principle should be followed for storing allergens and non-allergen ingredients. If possible, dedicated areas should be marked in the warehouse for storage of specific allergens.
Formulations and Scheduling – Formulas must be reviewed to identify allergens in those products. This will assist in developing appropriate scheduling of when those products should be produced. In general, products without allergens should be produced first and then followed by products containing allergens. Any time a product is produced that does not contain an allergen from a previous product, appropriate cleaning must take place to remove the previous food and allergen residues.
Tools and utensils – Care must be taken to ensure brushes, scoops, scrapers, knives, vacuum nozzles, etc. are dedicated to specific products or that effective cleaning is undertaken to prevent possible cross-contact or cross contamination. Color coding or labeling of these items may assist in tracking which items can be safely used during production of various products.
Personnel – People can also be a potential for cross-contact of allergens. This may include issues of employees returning from lunch breaks, handling of allergens in minor ingredient areas, or working between lines with different allergens. Protocols should be implemented to ensure people are not the vector of transferring different allergens to different food products. Items to consider should include proper handwashing, management of uniforms, dedicated personnel to specific production lines, etc.
Rework – If rework is handled in the facility, special care should be taken to prevent cross-contact or cross contamination issues. Any containers utilized to hold or transfer rework must be appropriately cleaned and labeled (product and lot or batch number.) Rework must only be blended back into products of the same type or only with products of the same allergens. Care should also be taken for cleaning of any equipment used to handle the rework materials, such as conveyors, grinders, blenders, etc.
Perhaps the greatest concern for effective ACP is in the packaging department. Wrong labels or packaging for a product is the most common reason for allergen recalls. In order to effectively manage packaging and labels, the following should be considered.
Personnel – Dedicating and limiting the number of employees allowed to handle and transfer labels from storage to packaging may reduce the risk. Checklists should be created to ensure verification protocols are in place to ensure the proper labels and packaging is taken to specific packaging lines.
Staging – In order to limit the potential for mix-ups in the packaging area, only the labels or packaging needed during that production run should be present in the packaging area. When change-overs are conducted, all previous packaging and labels should be removed from the area and equipment, and then the new materials brought into the area.
Obsolete Labels and Packaging – If these materials become outdated because of formulation or other changes to the product, obsolete labels and packaging should be removed from the facility or placed in a secured area until appropriate disposition and removal can be completed.
Verification of Allergen Cleaning
The Preventive Controls for Human Food regulation requires verification that allergen cleaning procedures were performed and were effective. There are several options for allergen verification and a company must evaluate the proper strategy for that specific food product or production line. Options to consider may include:
- Visually clean – minimum requirement; no residue, film or sheen
- Allergen Tests
- Non-specific tests, e.g. ATP (adenosine triphosphate) and protein
- May not be sensitive enough to detect some allergens
- Allergen Test Kits
- Specific protein testing kits available for many, but not all food allergens
- Training and Education
It is crucial that all employees receive allergen training and education so that they fully understand the importance of following ACP policies and procedures. Employees are the backbone of effective food safety programs.
In order to produce a safe food product, ensuring proper allergen labeling and limiting potential cross-contact issues, an effective Allergen Control Program (ACP) must be developed and managed by each food company to limit possible risk to people with food allergies. Careful review of regulations for specific food products and countries of possible export for those food should be undertaken by each food company.