Food allergens: how regulations are changing the global food safety landscape

Food allergies are on the rise. Studies show that food allergies are increasing around the world, for both children and adults.1 Scientists are researching ways to reverse or treat allergies, but the only current treatment – besides antihistamines to reduce symptoms – is to avoid consuming specific foods that trigger reactions.

Avoiding allergens in foods can be tricky. At restaurants and family gatherings, you don’t always know what ingredients are in a dish. And, even if you eat packaged foods, reading the labels isn’t always a guarantee. Someone with a dairy allergy may not be expecting to look for ingredients like casein or whey, for example.

It’s important for food manufacturers to clearly and accurately label allergens in their products in an understandable way. Globally, regulations and recommendations for allergens include declaring known allergens on labels.

Allergen regulations around the world

The Food and Drug Administration enacted the Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2004, which became effective in the United States in 2006.2 Under this regulation, eight food groups were listed as major food allergens that should be declared on the label: milk, egg, fish, crustacean shellfish, tree nuts, peanuts, wheat and soybeans. Traditionally these are known as the ‘big 8.’

Allergen-testing-food-safety-3m-environmental-monitoring-big-8In Europe, the EU Food Information for Consumers Regulation No. 1169/2011 (EU FIC)3 and the Food Information Regulations (FIR)4 2015 indicate that all food businesses should declare 14 major allergens: This includes the ‘big 8,’ plus celery, mustard, sesame, mollusk, lupin and cereals containing gluten.

Globally, CODEX, which sets international food standards, guidelines and codes of practice, states that the ‘big 8’ allergens in addition to cereals containing gluten should always be declared. This is in section of General Standards for the Labelling of Prepackaged Foods.5

Sulfites are not considered an allergen but can cause symptoms that are similar to those caused by food allergens. European regulators are continuing to study the effects of sulfites and determining what information should be included on food labels. Sulfites are also contemplated within the declaration of allergenic foods in the European regulation as well as CODEX.

Countries including Australia, New Zealand, Japan, Canada, Argentina, Mexico and Brazil have similar requirements for the ‘big 8’ and additional known food allergens.6 Many foods can elicit an allergic reaction, but the foods listed in regulations cause most of the cases of food allergies.2

Because food preferences and consumption habits vary by culture and country, there are local differences in deciding which food allergens should be declared. Since more and more foods are being exported, food manufacturers should consider their global consumers’ needs when declaring allergens on labels.

Preventing recalls with labeling and avoiding cross-contamination

Data in the US shows that more than 40 percent of food recalls are the result of undeclared allergens.7,8 Many of these recalls are caused by incorrect labeling or unintended contamination with food allergens. Food producers and manufacturers should study their practices to ensure they are clearly declaring allergens on labels. They should also take steps to prevent cross-contamination during the manufacturing process.

Prevention is the key to avoiding high-cost recalls and food waste due to contamination. The Food Safety Modernization Act (FSMA) and the proposed Code of Practice on Food Allergen Management for Food Business Operators both take a preventative approach that allow food manufacturers to establish allergen control plans that include strategies and procedures to ensure the declaration of allergens and to prevent unintended contamination.

Allergens_LMF_Final-almondsFacilities often use the same equipment and spaces for multiple food and beverage products. So, they need robust programs to clean and monitor manufacturing equipment between production runs to ensure no allergens reach foods not intended to contain that ingredient.

A few approaches can be taken with allergen testing – usually either specific or non-specific allergen tests. Specific allergen tests detect proteins from the allergenic food. They can be used to identify or quantify the amount of allergenic food present in the sample. For example, if a facility makes peanut butter ice cream, and wants to follow it with a run of peanut-free ice cream, they need to ensure the peanut proteins are completely removed from the equipment.

Most facilities use specific allergen tests, but, in some cases, non-specific tests are more useful in lines where multiple allergens are in a product. However, it should be considered that the sensitivity of protein swabs is usually lower than protein-specific tests like LFDs.  Certain swabs can be marked as high sensitivity, but still, it is important to verify that the level of detection is adequate to assess the risk of allergens on a surface.

As with other environmental monitoring programs, allergen testing should use a variety of sampling sites. The testing areas could be most focused on the direct contact zones and indirect contact zones. But periodically sampling all environmental areas for residue build-up that has the potential for cross-contamination also is valuable.

Protecting consumers from allergens is important to food manufacturers. That means ensuring labels are accurate and preventing the unintentional introduction of allergens into food products.

Additional Resources

Did you know there’s a comprehensive reference for environmental monitoring? The Environmental Monitoring Handbook features an entire chapter on Allergen Testing. Learn more about the importance of environmental monitoring and the steps you can take to be more proactive about food safety in your facility. Download the full handbook by visiting 3M Environmental Monitoring.


Each chapter includes in-depth guidance on important topics for food processing and handling facilities.


  • Osborne, N.J. et al. (2011). Prevalence of challenge-proven IgE-mediated food allergy using population-based sampling and predetermined challenge criteria in infants. Journal of Allergy and Clinical Immunology. 127:668-676.
  • Food and Drug Administration (2006). Food Allergen Labeling and consumer Protection Act of 2004. Public Law 108-282, Title II.
  • Regulation (EU) No 1169/2011 of The European Parliament of the Council of 25 October 2011. (2011). Official Journal of the European Union. Annex II. Substances or Products Causing Allergies or Intolerances.
  • Food Standards Agency. (2015). Food allergen labelling and information requirements under the EU Food Information for consumers Regulation No. 1169/2011: Technical guidance.
  • (1985). Codex General Standard for the Labelling of Prepackaged Foods. CODEX STAN 1-1985 (Rev. 1.1991).
  • Food Allergy Research and Resource Program. (2017). Food Allergens – International Regulatory Chart. Accessed May 25 2019.
  • Food Allergy Research and Resource Program. (2019). USA: FDA and USDA Food Recall Incidents. Accessed June 2, 2019.
  • Maberry, T. (2018). A Look Back at 2017 Food recalls. Food Safety Magazine. February 6, 2018.

Meet the Authors

Author: Gabriela Lopez Velasco Ph.D.

Dr. Gabriela Lopez Velasco, based in St. Paul Minnesota, has been a global technical service specialist at 3M Food Safety since 2015. She works as part of the global technical service and application engineer teams leveraging her expertise in food safety to provide technical training and application of 3M Food Safety portfolio. She currently oversees the 3M™ Allergen Testing platform. She received a degree in food chemistry from the National Autonomous University of Mexico (UNAM) and her doctorate in food science and technology from Virginia Polytechnic Institute and State University. She worked as a postdoctoral researcher at the University of California, Davis.

Author: Ken Davenport Ph.D.

Dr. Ken Davenport earned his undergraduate degree in chemistry from Spring Arbor University, his Ph.D. from the Department of Biochemistry at Rice University, and an MBA from the University of Minnesota. With more than 18 years of experience in the food industry and 21 years of experience with rapid method development and applications, he has a broad and deep background in both chemical and microbial food safety.

Currently, he leads a group of scientists at 3M Food Safety Department headquarters in St. Paul, MN, where they continue to push the boundaries on new technologies for the detection of chemical and microbial contaminants in food and the food manufacturing environment.