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Allergens are a major source of food product recalls

Allergens create a variety of challenges and can be very costly for food manufacturers when not properly controlled.

Although food recalls tied to illness outbreaks tend to garner the most attention, undeclared allergens in food are a leading cause of product recalls.

Over a recent 60-day period, nearly half of all food recalls posted by the Food and Drug Administration were tied to undeclared allergens.

In 2016, the U.S. Department of Agriculture reported 34 of the 122 food recalls under its jurisdiction were because of undeclared allergens. That’s more recalls than caused by E. coli, Salmonella and Listeria contamination, according to Food Safety News.

More than 30,000 emergency room visits annually are due to food allergy anaphylaxis, and nearly 150 people die from food allergies, according to the FDA’s Center for Food Safety and Applied Nutrition.

Food and beverage manufacturers of all types can be at risk due to allergens, although bakers and other manufacturers that handle multiple allergens tend to face the biggest challenges.

Foods often are recalled due to labeling issues pertaining to allergens, particularly stemming from cross-contamination due to weak procedures in the plant.

The Food Allergen Labeling and Consumer Protection Act of 2004 requires that packaged food labels include declarations of a group of eight major food allergens: milk, eggs, wheat, peanuts, soy, tree nuts, fish and shellfish.

These account for about 90 percent of all food allergies in the United States and must be declared on any processed food under the law, which went into effect in 2006.

In many cases, problems stem from the mislabeling of products that contain allergens. Line clearances and label checks are essential to preventing mislabeling issues.

It’s vitally important to conduct allergen awareness training every year, and appropriate steps need to be taken to avoid accidental contamination. Food manufacturers must focus on establishing proper and validated cleaning procedures for food production equipment to prevent food contamination due to allergens.

Production scheduling and segregation of manufacturing processes is also highly critical. For instance, a non-allergen product should never be processed after a product that contains allergens without performing a validated cleaning procedure.

For companies that export their products, it’s important to note that countries outside the United States identify different allergens. For instance, celery and mustard are considered allergens in Canada but not in the United States.

Proactively addressing food allergens can protect your company’s brand identity and integrity. Product recalls often lead to panic among consumers. It can be expensive for a food manufacturer to retrieve all contaminated products. More important, a recall can do major damage, sometimes permanently, to a company’s brand name.

Although there are exceptions to the law for small and very small food manufacturers, it’s still strongly recommended that companies develop allergen control programs, regardless of their size.

Allergen prevention control programs are a requirement under the U.S Food and Drug Administration’s Food Safety Modernization Act, the most sweeping reform of our food safety laws in more than 70 years.

All rules that are part of the law are in effect, although there are staggered compliance and enforcement dates, some tied to the size of the business. In the event your company is faced with a product recall, the WMEP can provide follow-up assistance by conducting an internal audit of food processes and procedures in your plant.

The Wisconsin Manufacturing Extension Partnership can assist companies in setting up allergen control programs. For more information and/or to set up an appointment, call (920) 850-6590 or go to

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