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CHECKLIST: 9 Considerations for Allergen Control in the Food Industry

Posted by Charles Giambrone


Allergen control in the food industry is under the microscope more than ever. Want proof? In 2019, undeclared allergens were the #1 cause of food recalls in the United States.

To keep consumers safe and your plant running, consider a thorough review of your allergen control checklist. The primary goals of any food allergen control program should be to:

  • Identify key team members
  • Prevent contact between allergenic and non-allergenic food
  • Ensure label accuracy
  • Document everything
  • Avoid regulatory missteps

With those goals in mind, here are the easiest and smartest ways to improve your food safety program:

9 Steps for Better Allergen Control in the Food Industry

Once you’ve got your team ready to go, discuss these nine components of an effective allergen control plan:

  1. Know your processing lines and products
  2. Plan allergen changeovers
  3. Review SSOPs
  4. Validate through studies
  5. Review changeover scenarios to determine test sites
  6. Determine the frequency of allergen validation
  7. Establish verification test methods and frequency
  8. Protect from cross-contact
  9. Fully document, with periodic finished-product testing


1. Know Your Processing Lines and Products

Keep track of the number of allergens in specific products and the production lines on which you produce them.

Any good allergen control policy starts at the beginning with the raw materials. It’s a no-brainer to ask your supplier for an allergen statement, but are you also asking for a list of any allergen used in their factory?

Are highly incompatible allergens (nuts, dairy, etc.) present in your supplier’s facility, including allergens that shouldn’t be in your product? At least once a year, test your supplier’s commitment to avoiding cross-contamination.

2. Plan Allergen Changeovers

First, get an understanding of the frequency of changeovers from one product -- with allergens A, B, and C -- to another product with its own set of allergens. Then determine the typical number of allergen changeovers on processing lines and equipment units each:

  • Day
  • Week
  • Month

For example, if you have only three changeovers on a line per month, the number of allergen verifications, validations, and revalidations should look far different from a line that has several changeovers per day.

From there, it’s time to schedule. Use clever thinking for changeovers from non-allergen to allergen products. Proper scheduling, whether daily or weekly, will let you clean the equipment and production line of allergens as close as possible to the next sanitation shift.

3. Review SSOPs

Check the SSOPs (Sanitation Standard Operating Procedures) for equipment and lines to determine the most effective cleaning regimen, food sanitation products, and labeling process.

Typically, you’ll want a chlorinated alkaline cleaner with the appropriate cleaning tools to efficiently remove the protein fraction that contains the allergens in question. For dry cleaning environments, effectively remove all removable subcomponents to clean in a controlled wet environment (i.e. a washroom). Use all dry cleaning and sanitizing tools and methods available to remove the allergen proteins.

As for labeling, follow these allergen sanitation procedures:

  • Keep similar labels as far away from each other as possible
  • Only keep one set of labels at the production line at a time
  • Before a production run, have two operators cross-check whether they’re using the right labels
  • Use an in-line barcode scanner to verify the label on all primary and secondary packaging

4. Validate Through Studies

Once you’ve established your choice of SSOPs, cleaning products, and equipment, conduct a proper validation study for ...

  • Each critical allergen type ...
  • For each changeover scenario …
  • On each processing line and piece of equipment

For initial validations, each study should consist of two or three replicates.

Ensure your crew is using the proper, approved test kits for each allergen. You can include kits both for food contact surfaces (e.g. Neogen Reveal 3D kits) and products (e.g. Neogen Alert and Neogen Veratox).

5. Review Changeover Scenarios to Determine Test Sites

When allergen testing in food products, think location, location, location. Not only do you need to analyze the proper Zone 1 and 2 sites to test; you also must choose the most problematic unique sites and surfaces.

Notably, some companies rely on dedicated lines for a given allergen. However, if that company wants to expand production capabilities, it may try to run more varied products on that line. Since testing results in held-up inventory, many such companies opt to test on-site to expedite results, especially with highly perishable food.

To avoid that testing-induced downtime, you could test a production run with the allergenic product, continuing that run until you find the cleaning method that best eliminates allergen residue.

6. Determine Frequency of Allergen Validation

Based on your HACCP (Hazard Analysis Critical Control Point) program risk assessment, determine the frequency of validation necessary for each type of allergen. Neither government regulators nor GFSI (Global Food Safety Initiative) certification bodies dictate how often each allergen validation must happen -- it’s up to you.

It could be yearly, semi-annual or quarterly. Whatever your decision, make sure it takes into account your HACCP assessment as well as the number and frequency of allergen changeovers.

Revalidate any food plant cleaning process:

  • When you add new products
  • When production process, staff, cleaning SOPs, or formulation changes
  • On a predetermined basis

7. Establish Verification Test Methods and Frequency

Once your initial validation studies are a success, set a schedule for rapid protein detection test procedures on equipment and processing lines.

The verification procedures for allergens includes a variety of tests:

  • Visual
  • ATP (adenosine triphosphate)
  • Sensitive protein

Note that ATP tests don’t single out allergen proteins, so only use them as supplements to antibody-specific tests.

Hygiena, 3M, Neogen, and R-Biopharm all manufacture rapid protein detection kits, with varying strengths. For example, Hygiena has both Pro Clean and AllerSnap, which both detect general protein residue. The AllerSnap has a greater degree of sensitivity but requires a heating block for swab samples. Pro Clean swabs don’t require a heating block.

Much like with validation, allergen verification frequency depends on the number of changeovers per day and per week. Use verification data for both post-OP and pre-OP environments.

Post-OP verification proves that allergen residue has been removed from production surfaces. Pre-OP verification results tell you whether it’s safe to begin the next production run.

How often you verify also depends on your risk assessment of the food in question. For high-risk products, verification tests should happen for every changeover. That frequency could decrease to monthly for medium-risk products and quarterly for low-risk products.

8. Protect From Cross-Contact

Your job is to safeguard all verified allergen-cleaned equipment from cross-contamination.

If your production equipment sits for hours after cleaning, it’s ripe for cross-contact with allergens. In these cases, your program must do at least one of the following:

  • Whenever possible, don’t manufacture allergenic products prior to non-allergenic ones on the same line
  • Move sanitation of the line to a time closer to its next production run
  • Isolate the cleaned equipment
  • Cover exposed cleaned equipment with poly sheeting
  • Schedule a recleaning and sanitizing SSOP

That first point is just as crucial during storage and transport as it is during production. 

Put allergens and non-allergens in separate warehouses if possible, or at least in separate storage locations in the same warehouse. Always place allergens on the bottom of any stacks, so that residue on the packaging doesn’t fall onto non-allergenic products. Finally, transport allergenic products separately from non-allergens if possible, or at least use an extra pallet cover.

Many food manufacturers color-code their storage units, production stations, and cleaning utensils to avoid accidental mixing. These designations vary by manufacturer. For example, one might label everything Zone 1-related in white to denote dry cleaning, while labeling Zone 2 with green to denote peanut allergens.

9. Document in Detail, With Periodic Finished-Product Testing

Allergen sanitation procedures must include painstakingly detailed documentation, audited by both internal and third-party consultants. This, in parallel with testing actual products you consider medium-to-high-risk, will close the loop in your comprehensive program.

Among other details, you should document:

  • Adequacy of equipment cleanup (before processing begins) 
  • Inspections of labeling on packages, either just prior to distribution or during production
  • Final product testing for the presence of allergens in non-allergenic products (noting which allergens were tested for)


Investing in Your Reputation

Food recalls are crippling to an industry that relies on reputation. Investing wisely in special allergen control training for food companies will arm you with tactics for:

  • Keeping allergens and non-allergens as separate as possible
  • Labeling and documenting diligently
  • Testing, studying, and improving all food safety processes

To learn more about your options in fighting allergen control in the food industry, click below:

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Topics: food industry, food safety

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