Allergen Management Tips for Food Manufacturers

Posted by Zosi Team

Allergenic foods pose a serious safety risk to your consumers, causing sometimes life-threatening medical reactions when exposed. As the CDC continues to report a rise in food allergies across age demographics, successful allergen management is an integral piece of food manufacturing.

Your company has an allergen control program to help prevent cross-contact between products that contain allergens and those that don’t, as well contact between products containing different allergens. While not exhaustive, this blog serves as an introduction to allergen management and provides a brief look at tactics you can use in your facility.

Allergen Management Best Practices

Developing an Effective Allergen Program

A well thought out allergen management program may include:

A risk analysis of raw materials, ingredients, and processing aids that could contain food allergens
An assessment of workplace-related food allergens, such as though coming from vending machines, visitors, and break rooms
A list of allergens in your country and your product’s destination made available to all relevant staff
Documented allergen controls included in your food safety plan
The hazards associated with allergens and their control incorporated into the food safety plan.
An allergen control management plan

Implementing an effective allergen program takes considerable research and foresight. Developing an allergen map that covers every step in your process, or building on an existing process flow, will prove useful as you appoint individuals to lead your program and educate your team. Sites must also take care to identify allergen concerns as chemical hazards in their food safety plan, which uses the existing process flow.

If a site does not handle allergenic material, they should still need to document, implement and maintain an allergen management program.

Identifying Allergens in Your Facility

With your allergen management program in place, all associated staff must be trained to identify, handle, store, and separate materials and products containing allergens. Under the Food Allergen Labeling and Consumer Protection Act (FALCPA) the FDA recognizes the following food allergens in the US:

Tree nuts—including almonds, walnuts, and hazelnuts, among others
Milk (not to be confused with lactose intolerance)
Crustacean shellfish (crab, lobster, crawfish, etc.)

Of course, food manufacturing sites should seek out the list of allergens in their country of manufacture and country or countries of destination. When the FDA issued guidance on the Big 8 in 2004, these allergens caused 90 percent of food allergies – making them the most common causes of severe food reactions in the United States. However, they do not currently represent all foods worldwide that people are allergic to (more than 160 foods!) or the most common causes of severe food reactions in other countries.

With the signing of the Food Allergy Safety, Treatment, Education, and Research
FASTER Act of 2021 into law, sesame will become the 9th major food allergen in the US as of January 1, 2023. Today, manufacturers do not need to list sesame as an allergen but should take care to note it as an ingredient. Exceptions include:

Sesame is part of a natural “flavor” or “spice”
Sesame is not in the common name for a food but is a primary ingredient, such as tahini

Allergen Management: Cross-Contact

Cross contact occurs when allergens are mixed into products that shouldn’t have them. To prevent this from occurring, food processors must implement allergen preventive controls. Allergen cross contact can take place if allergen residue from a previous run is not completely removed from equipment before a new product is run through, in receiving and storage areas, or when products are being formulated or processed.

Tactics for Cross-Contact Prevention

Again, to help prevent cross-contact, your company must have a compliant allergen control program. The program also works to prevent contact between products containing DIFFERENT allergens, such as pecans and peanuts, or wheat and soy.

At the receiving dock, we can help prevent cross-contact as soon as a shipment arrives. Once a shipment is verified, check it for product spills, and open or damaged containers. Damaged packaging allows the contents to spill out and get into other ingredients. After shipments are inspected, store the allergenic ingredients in the areas designated by your company. Your company may use a simplified allergen labeling system so that they can be easily identified while in storage and may likely store allergens separately from non-allergens. However, if this is not possible always place the allergens BELOW the non-allergens. This same rule also applies to storing a single allergen next to foods with multiple allergens. For example, you should place an ingredient containing both milk and soy BELOW an ingredient that only contains milk.

Cross contact can also occur during product formulation. For instance, if the wrong ingredients are accidentally included in a recipe during this step. One way to prevent this from happening is by using a different tool for each ingredient, such as using dedicated tools for each allergen, or by cleaning and sanitizing a tool after it has been used.

Another area where cross-contact can occur is when rework products are used. Rework products should be labeled and tracked right up until they are used. Follow your company’s rework policies exactly. If a rework product is combined with the wrong ingredients, it could contaminate an entire batch.

Finally, always remember to follow your facility’s personal hygiene requirements if you work with allergens, such as changing gloves, smock, and so on.

Cross-Contact Prevention: Proper Sanitation

Production timing, processing lines, facility traffic, human error, equipment type, and more all present risk of cross-contact. For example, inadequate sanitation can leave residue that introduces allergens from the equipment surface into product material. Food contact surfaces should be visibly clean as a starting point when products produced contain different allergens. Equipment, tools, and surfaces must be thoroughly cleaned before processing product that does not contain the same allergen profile.

Facilities must maintain a record that documents cleaning between products that contain different allergens. This could be recorded as a sanitation record or an allergen scheduling record. Always remember to use a format that clarifies what must be done to meet the needs of your operation. Validated allergen-specific test kits are available for some food allergens and can be used to detect the presence of food allergens on food-contact surfaces using swabs. Push-through material can also be evaluated to establish safe times and volumes for such a procedure.

You must provide dedicated tools and equipment wherever these sanitation and allergen management best practices are not possible.

Allergen Management: Labeling & Ingredients

People with food allergies rely on accurate food labels to tell them what allergens are present in products. The food label is our promise that we’ve only included the ingredients that are listed on the label in that product or have advised the consumer that the product may contain allergens not listed because it was prepared in a facility with those allergens. However, sometimes allergens do end up in foods without being declared on the label. Most often this happens because of a labeling mistake in the factory. Regardless, undeclared allergens are one of the single biggest reasons for ALL of the food product recalls that happen every year. These types of recalls are even more common than recalls resulting from biological contaminants like Salmonella or E. coli. The average cost of a single food recall to a food company is $10 million. So, a mistake as simple as accidentally putting an outdated label on one batch of finished goods could have serious consequences, both for your company and for all your consumers.

By law, food manufacturers are responsible for ensuring that packaged foods only contain the ingredients that are listed on the product label. An effective system for product and ingredient identification allows for full traceback of ingredients and processing aids. Finished product labels must be true and accurate. When labeling a product containing a food allergen, the label must be specific to the allergen to inform the consumer who has an allergy to one food in a group. For example, if tree nuts are present, then the specific tree nut(s) must be included on the label.

Your facility should identify an allergen label preventive control with label checks at least at the beginning, middle, and end of each production run, and preferably at each label changeover. You may also want to implement a line clearance procedure, wherein all labels and products from the previous run are completely removed – leaving no chance of cross-contamination or mislabeled products on the next run.


Human error can be involved in all of the common causes of undeclared allergens in food products. Your allergen management program is only effective when all relevant staff understands its importance and their role in upholding food safety. To learn more about allergen management for food manufacturers, click here.

Subscribe to Insider Insights

Zosi needs the contact information you provide to us to contact you about our products and services. You may unsubscribe from these communications at any time. For information on how to unsubscribe, as well as our privacy practices and commitment to protecting your privacy, please review our Privacy Policy.

Related Courses

Newsletter Icon Never Miss an Update. Sign Up for Zosi’s e-Newsletter.