Various food allergens on gradient background

How to Have a World-Class Allergen Management Program

Denis Storey
June 1, 2021

eBook: “9 Things Your Allergen Control Program Is Missing”

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“9 Things Your Allergen Control Program Is Missing” eBook

Are cumbersome manual processes threatening the integrity of your allergen program? TraceGains and AIB International have joined forces to produce a practical eBook that can help finally put your allergen control puzzle together.

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Purchasing ingredients from suppliers doesn’t necessarily mean sources are equally stringent about allergen management. To reduce this liability, food and beverage manufacturers require suppliers to have a unique allergen map and lettered documentation declaring the items are free from contact with food allergens.

The FDA food label law recognizes the Big 8 food allergens as:

  • Peanuts.

  • Tree nuts — including almonds, walnuts, and hazelnuts, among others.

  • Milk (not to be confused with lactose intolerance).

  • Eggs.

  • Wheat.

  • Soy.

  • Fish.

  • Crustacean shellfish (crab, lobster, crawfish, etc.).

  • While not considered a true allergen, sulfites do require labeling at greater than 10 parts per million (ppm).

Additionally, if you’re making products and shipping them outside the United States, certain countries might have different allergens. Hence, manufacturers need to be up to date on what those might be.

While it’s lawful to add food allergens as ingredients to human food, the Food Allergy Labeling and Consumer Protection Act (FALCPA) added section 403(w) to the Food Drug and Cosmetic Act (FD&C Act) in 2004 to specify the label declaration requirements for significant food allergens.

FSMA Adds New Food Allergen Requirements 

Over the last 15 years or so, there’s been a spike in food allergen recalls because of cross-contamination or cross-contact and mislabeling. More than a third of these recalls were due to undeclared allergens, which pose food safety risks to consumers and jeopardize brand integrity. FSMA included requirements for food allergen preventative controls to combat allergen recalls. These corrective actions and best practices include better supply chain management, good manufacturing practices (GMPs), and proper labeling.

With complex supply chain systems and improved sourcing of ingredients, the supply chain management system can present a risk to ingredient integrity. In addition to supply chain management systems, significant contributors to allergen cross-contamination or cross-contact are potentially ineffective GMPs. Allergen preventative control requires companies to control ingredients with allergens from receipt to the finished goods shipment.

So how do you go about implementing a world-class allergen management program? We sat down with Elise Forward of Forward Food Solutions to explain how to take allergen control plans to the next level.

How to Have a World-Class Allergen Management Program

Where do allergen risks originate? If you’re handling allergens in your facility, the facility is always a potential risk. However, you also can have supply chain risks that happen through transportation, warehouses, ingredients, and packaging. And anywhere where these allergens are processed is also considered a risk.


Keeping these risk areas in mind, you want to take a critical look at your potential cross-contamination points. As many have either completed or are working through their food safety plans, it’s important to remember that allergens are considered chemical contaminants. You need to keep this in mind when building out those plans.

Understand traffic patterns: You need to understand your traffic patterns. Where does that allergen move in your facility? Does it go into three different rooms? Can you move it so that it’s only in a single room?

It’s critical to understand how allergens move from the warehouse into the facility, and out the door again. If you can, set up physical barriers, such as walls, to isolate the allergen into a specific area and control it that way. If possible, use separate equipment.

Your Facility: In your receiving areas, you want to make sure that anyone receiving any ingredient – or any item coming into the plant – knows what the potential allergens are, has some adequate allergen training, and knows which products have allergens in them.

You’ll want to do some new labeling with brightly colored labels. For example, if you have a peanut product coming in, put a bright pink sticker on it that says “peanuts” so everyone can see it.

Additionally, if you’re working in a multilingual situation, you might need to use a pictorial label.

Go the extra mile: If, for example, you’re marketing products to the allergen-free crowd, you can take more precautions to go the extra mile. For example, you can:

  • Wipe down or vacuum all exterior packaging.

  • Require shippers to use extra packaging to protect product during transport (especially if you’re using less than load shipments (LTLs), as you don’t know what else is on the truck, what was shipped before, if something spilled, etc.)

  • Use Gaylord boxes or a cardboard wrap and extra shrink wrap.

  • Re-palletize, removing all exterior packaging and conducting wipe-down/cleaning of the product at the receiving docks before it enters the plant.

These steps are above and beyond what many companies do, but if you’re working in a highly sensitive area, this might be standard operating procedure.

Label and Labeling

Sadly, and most easily rectified, the most significant factor for allergen recalls is due to mislabeling. Since nearly 11% of the total adult population in the United States have food allergies, according to JAMA, it’s crucial to have a detailed process for checking the accuracy of your labels.

Ideally, you should be checking labels in a four-step process:

  1. Upon creation of your labels.

  2. Receipt of your labels.

  3. When your labels go to production.

  4. During a finished product check. 

You also can do a check as you’re shipping products out the door. There tends to be a case packaging step, and you want to ensure what you’re shipping is the right product.

Additionally, you always want to do a label review whenever there’s a change in a formula as part of your food safety plan review if there’s any change in your ingredient supply chain or manufacturing process.

Supply Chain Controls

It’s important to talk about supply chain controls as well. You already know the risks within your facility, but you inherit any issues your suppliers or your suppliers’ suppliers have when those products and ingredients come through your door. And some products take quite a journey to get to your plant.


Transportation can be affected by the type of truck used, mainly if that includes bulk shipments. Let’s look at oats as an example. For gluten-free people, many tend to stay away from regular oats because the equipment used to process oats also are used to process wheat. Companies making gluten-free oats go to great lengths to keep all that separate and to clean transportation/equipment appropriately to manage the potential cross-contamination.

Questions to ask include:

  • What kind of truck is used?

  • What did it haul last?

  • How was the truck cleaned?

  • What testing was done or can be done?

If you’re making a susceptible product, like the gluten-free oats example above, it might be wise to use a dedicated truck versus LTLs, potentially putting your product at risk. Of course, this will add cost to your product production, but if it lowers your risk, it becomes a benefit.

FSMA Tip: With the new Sanitary Transportation rule, trucking companies now must increase their food safety and quality programs, which is an excellent opportunity to educate your partners and help them to learn more about these practices. 


When it comes to ingredients, you need to understand your supply chain to understand your allergen risk. There are several times when a company ultimately ends up with a recall due to incoming contaminated material. It helps consider what other types of products might be manufactured in that supplier’s facility to better understand the potential risk with your incoming ingredients. Knowing what else the facility produces in the same plant is an excellent way to discover potential risks. 

Additionally, processing aids can sometimes cause a direct allergen risk or help identify essential information about additional products manufactured in the facility. For example, sulfites, soy lecithin, and other pan release agents need to be labeled.

Managing Supply Chain Partners

What do your suppliers’ allergen programs look like? What do they require of their suppliers? What do their cleanout programs look like, and what kinds of testing do they do? How do they prevent cross-contamination? These are all questions you should be asking as they relate to your supply chain controls.

Depending on the sensitivity of your product, you might need to ask more questions. If there’s an allergen found in your product that doesn’t belong, it’s your responsibility. That “may contain” statement on your label doesn’t give you an out for cross-contamination.


Warehouses can sometimes be an exciting challenge, as some don’t just warehouse food, which means you also need to understand how these warehouses manage allergens.

A few questions to ask include:

  • Are they following the rules of non-allergenic material over allergen material?

  • Do they store allergens in different areas, or do they have a room dedicated to the storage of allergenic material?

  • Do they have a color-coding system or a placard system in place?

  • What happens when a product breaks, and there is a spill?

  • If there is a spill, do they notify the customer?

  • What do they do for documentation?


There are some types of packaging, like paperboard, where, in the past, they used to use wheat in it. It’s not as common anymore, but it’s still an excellent question to ask, which can simply be a question for your packaging suppliers, asking if they use any of the Big 8 in their facilities. If they do, then you need to determine how they control these allergens and ask similar questions to those listed above.

How can software help with some of these challenges?

If you’re looking to ease the burden of managing your allergen program, software can help.

For example, Supplier Management from TraceGains automates the process of collecting the different documents you require from suppliers for all items/ingredients you purchase, including your allergen documentation. This information is then transferred into an actual database, allowing you access to actionable insights in real-time. 

Tie it into managing within the four walls with Quality Management. This software can ensure that everything required by your food safety plan and preventative controls is happening. So, suppose you have specific controls in place to check lines before production starts or perform other activities to segregate inventory in your warehouse. In that case, TraceGains allows you to record that electronically, instantly alerting you to unfinished tasks.

As we’ve mentioned before, there’s a significant shift in focus when it comes to allergens. The FDA is looking at undeclared allergens in a new way and no longer treating them as a recommendation. You need to make sure you’re documenting and following an operating procedure that ensures your allergens are declared properly when a product leaves your facility.

TraceGains and AIB International have joined forces to produce “9 Things Your Allergen Control Program Is Missing,” a practical eBook that can finally put your allergen control puzzle together.