The Food Safety Modernization Act (FSMA), 21 CFR Part 117, significantly shifted the focus to “allergen cross-contact” from its earlier food-safety iteration of Good Manufacturing Practices (GMPs) found in 21 CFR Part 110.
The term “allergen cross-contact” was not even mentioned in Part 110, but it appears 37 times in Part 117, indicating the priority U.S. FDA places on prevention.
With sesame the latest addition to the FDA’s “Big List” of food allergens, and undeclared allergens the top reason for food recalls in 2023, it’s clear that developing allergen controls and avoiding allergen cross-contact are more important than ever for food manufacturers.
In this article, we provide key points to consider when developing your preventive allergen controls.
Allergen cross-contact occurs when a non-allergenic food comes into contact with an allergenic food, leading to the unintentional transfer of allergens.
This can happen during various stages of food processing and handling, including production, packaging, and storage.
Though the terms are often used interchangeably, there are differences.
Allergen cross-contamination is a sub-category of cross-contact. It refers to the contamination of food products with allergenic food due to poor hygiene practices or improper handling.
In the case of allergen cross-contact, picture a food handler using a container that contained wheat to store a different product without sanitizing it first. The handler may inadvertently transfer a small amount of wheat to the other product, triggering an adverse reaction.
In the case of allergen cross-contamination, picture a food handler cutting meat and then switching to another ingredient without washing the knife. Cross-contamination can occur due to poor handling.
Most food allergies are caused by one or more allergenic proteins. FDA includes nine major food allergens in its “Big List”:
The presence of any of these nine allergens must be declared on a product’s label in accordance with the Food Allergen Labeling and Consumer Protection Act (FALCPA).
Both the U.S. food and dietary supplement industries are subject to FALCPA, which requires the allergen to be listed using its common name, making preventive allergen controls a necessary part of your process.
A note of exemption: Highly refined oils are exempt if processing removes all traces of the allergen.
Undeclared allergens continue to be responsible for the highest percentage of reported food recalls. They enter the food supply through…
Implementing effective allergen controls can address these inadvertent errors.
In other instances, allergens are knowingly included in the product, but their declaration on the label is intentionally and illegally avoided.
If this intentional adulteration is for economic gain, then the practice is known as “food fraud”.
However, if the adulteration is with the intent to cause harm, then it falls under the category of “food defense”.
In FDA’s eyes, the inclusion of an undeclared allergen in food or dietary supplements is an egregious error and can be punished through one or more FDA enforcement actions.
The U.S. FDA has published a helpful document entitled “Allergen Cross-Contact Prevention” that contains tips for developing preventive allergen controls that guard against allergen cross-contact in food manufacturing facilities. Here are the highlights, but consult the document for details:
Switching suppliers is a major factor in potential allergen cross-contact in food manufacturing, as the Covid-19 pandemic showed. Supply chain problems are still plaguing many manufacturers, which increases risk, especially when different suppliers have varying allergen control practices.
Here's how to mitigate this risk:
Laboratory testing for allergens plays a crucial role in identifying allergens, either within the processing facility or through an independent third-party lab. Key methods include:
These testing methods help quantify and confirm the presence of allergens, ensuring food safety compliance.
Allergen changeover testing, when more than one product is produced on the same production line, is used to validate efficiency of sanitation. Cleaning is not enough to prevent allergen cross-contact; sanitizing and confirmation testing must follow.
Test products made in the first run after cleaning and sanitizing is complete to assess changeover effectiveness.
If positive results are found, corrective actions, including recleaning and sanitizing, must be undertaken, and that first-run product should be held or destroyed.
A single test may give an incomplete picture; therefore, a risk-based approach includes routine and random testing of equipment surfaces and food in appropriate intervals by zone, such as with an environmental monitoring program.
FSMA requires that both domestic and foreign food facilities conduct a hazard analysis for foreseeable food-safety risks, including the introduction of allergens, and to implement a system of risk-based preventive controls for those identified hazards.
Known as Hazard Analysis and Risk-Based Preventative Controls, an allergen control program is included as part of this hazard assessment and preventive strategy.
Allergen control programs are a must for both domestic food processors and their suppliers, including importers of food products. Steven Gendel, former FDA Food Allergen Coordinator, provides tips for designing your allergen control program here.
Integral to the overall preventive control-based food-safety program, monitoring for introduction of allergens, developing and implementing corrective-action procedures as necessary, and allergen testing are three major components.
Food safety testing laboratories must have the equipment, methods, and expertise to ensure accurate identification of allergens. ISO 17025 accreditation demonstrates competency and provides assurance of accurate, traceable, and reproducible data based.
If you need allergen testing, Certified Laboratories can help.
Our regulatory partners at EAS Consulting Group, a Certified Group Company, can help you develop and assess your Hazard Analysis and Preventive Controls as well as your allergen control program at the supplier and manufacturer level.
For more on food allergen controls, check out our free webinar: Food Allergens and the FDA