Food Allergen Control in the U.S.

Food allergies occur when the body’s immune system overreacts to a harmless food protein (an allergen). Food allergies are different from food intolerance, and sometimes food allergy symptoms overlap with symptoms of other medical conditions. This is a serious and potentially life-threatening medical condition affecting 10 to 40% of people worldwide. Food Safety: Allergen Control maintains that being aware of the major allergens in a food processing facility is critical when it comes to creating a safe, quality product for customers. There is no cure for food allergies. Strict avoidance of food allergens, early recognition and management of allergic reactions to food are important measures to prevent serious health consequences.

Internationally, there is a growing recognition that food allergy is an important public health issue that requires information to protect sensitive consumers, and therefore Directive 2003/89/EC (European Parliament, 2003) and the US Food Labeling and Consumer Protection Act ( FALCPA) (US Code, 2004) were issued. Subsequently, other countries adopted a regulatory framework for allergen labeling. In recent years, significant progress has been made in implementing laws on food allergy management in the United States. In particular, many states have also enacted relevant laws. There are five states that require restaurants to post food allergen signs and/or implement food allergen training for restaurant managers. Many states now require local schools to develop food allergy management programs.

Food packaging labeling has been improved by the Food Allergen Label and Consumer Protection Act of 2004. Food allergy has been established as disability by a federal law (American Disability Amendment Act 2008). Food Safety Modernization Act requires the same level of manufacturing control over food allergens as previously applied to foodborne pathogens, while helping the state government by raising awareness of food allergies and food allergens. The federal initiative also provides sample documents that can be adapted to national use (such as the FDA Code and Food Allergy Management Guidelines) and provides fiscal incentives for states to adopt food allergy management guidelines.

The role of the FDA :

• FDA is working on three fronts to reduce potential food allergen risks: researching the causes of labeling errors, working with industry to research best practices, and developing new ways to detect the presence of allergens. The Food Safety Modernization Act (FSMA) specifically addresses the Hazard Analysis and Risk Based Preventive Controls (HARPC) portion of the Preventive Controls Rule, which requires the control of allergens and the revision of good manufacturing practices (GMPs).

• FDA conducts inspections of food companies and has the authority to request companies to recall products containing undeclared food allergens. FDA has established and manages the Reportable Food Registry (RFR or the Registry) - an electronic portal for Industry to report when there is reasonable probability that an article of food will cause serious adverse health consequences. The Registry helps the FDA better protect public health by pattern tracking and targeted inspections.

• FDA Consumer Complaint Coordinator in many regions are receiving complaints from consumers about food allergies.

Related legislations

The Food Allergen Labeling and Consumer Protection Act (FALCPA) is a United States law that requires all food labels in the United States to list ingredients that may cause allergic reactions in simple language and has been in effect since January 1, 2006. Although many ingredients can trigger food allergies, this legislation only identifies eight foods or food groups as the major allergens, which are estimated to trigger 90% of allergic reactions. They are milk, eggs, fish, crustacean shellfish (e.g. shrimp, crab, lobster), tree nuts (e.g. almonds, walnuts, pecans, etc.), peanuts, wheat and soybeans.

On a worldwide basis, the Codex Alimentarius Commission has established a list of common allergenic foods. Specific countries have their own distinct list of common allergenic foods. A compilation of the lists of various countries is available at www.farrp.org.

For food companies, Allergen Control Plan should be written regarding the storage, handling, processing, packaging and identification of allergenic foods or ingredients. The Allergen Control Plan must be implemented, audited, enforced and updated continually.

Attached: International allergen labeling requirements:

References

• Gendel, S. M. (2012) ‘Comparison of international food allergen labeling regulations’, Regulatory Toxicology and Pharmacology, 63(2): 279-285.

• Bedale, W. (2018) ‘Current US State Legislation Related to Food Allergen Management’, In Food Allergens pp. 55-73.

• https://farrp.unl.edu/f0c3a875-ce07-404f-b05f-8a7983e57daa.pdf (Fig 1)

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