The government and food industry both have increased their focus on food allergenicity issues. Strategies in developing, manufacturing and marketing safe foods involve departments as diverse as R&D, marketing and plant operations including sanitization. The following article has been condensed and adapted from the original published in the February 2005 issue of Dairy Foods magazine. --Eds.

An estimated 11 million Americans have food allergies, including 4%-8% of children and 1%-2% of adults. Food-allergic reactions are estimated to cause 29,000 emergency room visits and 150-200 deaths per year. No processor wants his product to be included in these statistics. An understanding of the foods that cause allergic reactions, controls that can reduce risk, and tools that can verify adequate control can reduce the risk that dairy and other food processors face when they produce products that contain a variety of allergens.

Defining Food Allergies

A true food allergy is a response in which the body's immune system overreacts to protein in the food. This should not be confused with food intolerance, such as lactose intolerance, that involves an enzyme deficiency or other non-immune issues. Allergic reactions can involve skin (hives), gastrointestinal (nausea, cramps, diarrhea), respiratory (struggle for air) and circulatory (blood pressure drop) symptoms. In extreme cases, anaphylaxis can occur (in which multiple organ systems are triggered), and death can follow in minutes.

All food allergens are naturally-occurring proteins that are very resistant to heat, proteolysis and pH. Trace amounts at parts per million levels can cause a reaction. Sensitivity and severity of reactions varies by individual and amount of the allergenic material present. Avoidance of the allergen is the only thing that an allergic individual can do to prevent a reaction.

Food allergy has existed for many years. Several groundbreaking reports published in the late 1980s and early 1990s heightened awareness of the food allergy issue, and product recalls began. The trend toward value-added products and the diversity of products in the marketplace has increased the combinations of ingredients used in products and this complicates allergen management for processors, thus the potential allergen exposure has increased.

While the percentage of individuals with diagnosed food allergies is relatively small, those that believe they have food allergies or purchase products for allergic individuals has been estimated to be as much as 30% of the population. These people are very brand loyal and purchase brands that they have consumed safely in the past.

The “Big Eight”

Eight foods are responsible for over 90% of all food allergic reactions. These are peanuts, tree nuts (such as cashews, almonds, walnuts, etc.), milk, eggs, soy, fish, shellfish (crustacean) and wheat. There are over 160 foods that can also cause allergic reactions, but the focus for control and regulatory action are on the so called “Big Eight” because controlling these will control the most prevalent and severe reactions. Soy, milk, egg and wheat allergies tend to be issues for children and they generally out grow their sensitivity to these foods. Allergy to crustaceans (shrimp, crab, lobster, etc.) and fish generally develop in adults, while peanut and tree nut allergy impacts both children and adults and persists throughout life.

Highly refined products derived from some of the Big Eight allergens may have the allergenic proteins removed. For example, highly refined soybean oil has not been shown to demonstrate allergic reactions.

Controlling Allergens

There are three basic control strategies for food allergens: 1) dedication, 2) separation and 3) labeling. For example, for dairy operations that process only milk and milk products, dedication is the answer. Milk is clearly labeled and those individuals with a milk allergy will avoid the product. However, the situation is not so simple for operations that produce items in addition to milk. When soy beverages or juice products are added to a fluid milk production schedule, allergens become a concern. Management issues are even more complex with products such as ice cream that may have nuts and particulates with allergens. Each type of nut can have different allergenic proteins so they must be treated as separate and distinct allergens. Filtering or screening these out of fluid mix does not remove all of the allergenic proteins that may elicit an allergic reaction.

When processing products that contain different allergenic ingredients, a plan is essential. A comprehensive “Allergen Prevention Plan” includes allergen mapping, ingredient control, packaging and labeling, system design, traffic patterns, work-in-process, maintenance, scheduling, effective cleaning and training.

n Allergen mapping: It is important to understand where allergens are in the plant and where they are introduced into the process. When the primary product is a food allergen, it will obviously be present throughout the facility. However, some products, such as ice cream, add ingredients at various stages throughout the process. Mapping where these additions are made can be very informative in determining where the potential for allergen cross contact becomes a concern and where control is needed. For example, particulates may be added to ice cream before or after the freezer. Addition after the freezer, if possible, can remove the potential for particulates to become trapped in freezer blades.

  • Ingredient control: Every processor should obtain detailed information from suppliers on all of the components that go into their ingredients to ensure that allergens are properly identified. It is also important to evaluate how suppliers control allergens. For example, it would be prudent to ensure that a nut supplier does not roast different kinds of nuts in the same oil, which could lead to cross contact of allergens.

  • Packaging and labeling: Labeling is the primary control tool that a consumer uses to avoid consumption of a food allergen. Because of this, it is essential the information on the label accurately identifies allergens present in the product. New allergen labeling regulations become effective on January 1, 2006. Effective control of labels requires a thorough review of all components in ingredients as described above, and allergens must be properly identified on the label. It is also important to review the labels upon receipt from the printer to check for printing errors. Finally, the label must be applied to the right product.

    Plant Operations Key

    Beyond allergen mapping at the plant level, other efforts should be undertaken. They can be categorized as follows:

  • System design: The same sanitary design principles that apply for microbiological control apply to allergen control. For particularly difficult to clean equipment, it is useful to have parallel modules with one dedicated to allergenic ingredients.

  • Traffic patterns: A careful review of the pattern that allergenic products, ingredients, and the people that work with them take in the plant must be done to evaluate the potential for this to occur.

  • Work-in-process and rework: All work-in-process and rework must be clearly labeled to identify those that contain allergens. It is recommended that rework containing unique allergens should be used only in the same formulation, that is, “exact into exact.” A periodic audit of rework practices is advisable to ensure continued application of effective allergen control practices.

  • Maintenance: Ongoing maintenance of all equipment is essential. It is important to include maintenance personnel in allergen system design and training to ensure that they are aware of the risks and, most importantly, to use their experience in identifying and designing effective controls for the issues that they have observed.

  • Scheduling: Dedicated production systems can reduce the need to evaluate scheduling as a means to control for allergens, but are not feasible. Longer production runs minimize the number of change-overs, and, thus, the potential for allergen concerns. Allergen-containing products should be run at the end of the production sequence.

  • Cleaning: Time requirements for cleaning to remove allergens depend on the complexity of the system and the type of soil. When evaluating the effectiveness of cleaning procedures for allergen control, it is important to focus on the result and not merely the process itself. In other words, it is essential to validate that the procedures used actually removed the allergens.

  • Training: Training is the key to sustaining an effective allergen control program. The basics of allergens should be covered to ensure that all employees understand the real health consequences that can result when products are not properly labeled.

    The need for effective allergen control is an ongoing concern. As consumers demand more variety in their products, the challenges faced by processors increase. However, careful planning and attention to superior cleaning and verification tools can control the issue.