Food businesses must provide allergen information to their customers via various methods depending on how they serve food, from providing prepacked foods directly on packaging itself, or offering it upon request at buffets and events.
Food allergens that account for 90 percent of allergic reactions in the US (1) include milk, eggs, wheat, soya beans, peanuts tree nuts fish and shellfish.
Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA)
Since 2004, FALCPA – or Food Allergen Labeling and Consumer Protection Act – has helped Americans with food allergies avoid potentially unsafe foods. The law mandates that foods regulated by the Food and Drug Administration (which cover almost all food except alcohol beverages and meat, egg and dairy products supervised by USDA) that contain one of eight major allergens be identified clearly; these include milk, eggs, fish, crustacean shellfish (such as shrimp or crab), tree nuts such as almonds pecans walnuts etc), wheat and peanuts which account for more than 90% of food allergy cases worldwide.
Not only must manufacturers identify major food allergens in their product, they must also disclose whether it contains them through either explicit statements or clear language such as “may contain,” “processed in facility that also processes” or “made on equipment that also produces” to warn of potential cross-contact between an allergen and their product. This practice is known as conditional precautionary statements.
Law requires manufacturers to use good manufacturing practices in order to limit accidental contamination of foods containing major allergens with unintentional contamination by implementing allergen preventative controls, including cleaning shared equipment, separating production lines and segregating allergens. AAFA supports policy steps taken by manufacturers in order to implement such practices correctly – in many instances class 2 recalls occur due to inaccurate ingredient declaration (e.g. butter is declared, but milk isn’t).
Food Allergen Labeling Requirements
FALCPA requires all foods regulated by the FDA to include allergen information on their labels, either listed as an ingredient in its ingredients list or separately as “Contains” statements that list eight major food allergens: peanuts; tree nuts; wheat and triticale; soy; milk; fish; crustacean shellfish; sesame.
The FDA allows companies to include a precautionary “May Contain” statement when there is any chance that allergens not listed on their ingredient list may be present in their food product. This type of warning statement is most frequently seen on products produced in facilities with multiple food production lines.
Food sold from delicatessen counters or restaurants must meet additional regulations regarding allergy labeling. Allergen information must be provided at two stages in the order process: when customers place their orders and when their food is being prepared.
TTB does not impose specific allergen labeling regulations for alcohol beverages; however, they recommend providing customers with information upon request and taking reasonable measures to prevent the accidental inclusion of allergens by keeping food preparation areas and equipment separate and taking other steps to minimize cross-contamination.
The Food and Drug Administration (FDA)
FDA is an agency of the United States federal government responsible for overseeing the safety, efficacy, and security of drugs used for humans and veterinary use, biological products, medical devices, food supply products and cosmetics that emit radiation as well as certain products that emit radiation. Furthermore, they aim to curb tobacco use among minors as well as provide accurate health information in an easy to access format for the general public.
The FDA conducts inspections on both foreign and domestic manufacturers, taking enforcement action when necessary – be that issuing warnings, seizing non-compliant products or legal proceedings against offenders. Furthermore, this agency constantly develops new testing methods to assess product safety and quality.
Additionally, the FDA regulates and oversees the safety of both prescription and over-the-counter pharmaceutical drugs (medications). Approval for drugs requires rigorous clinical trials that assess their intended uses as well as potential benefits and risks; once on the market, however, the FDA regularly monitors them.
Failing to declare allergens can result in severe, potentially life-threatening reactions. When such reactions are reported to the CFIA, laboratory methods are developed for identifying undisclosed allergens in foods – these tests then become part of FDA inspections and enforcement of labelling requirements.
Threshold Levels
Food-allergic individuals typically have individual threshold doses below which they do not experience adverse reactions, providing a way for them to effectively manage their allergy by selecting food products within this limit. Individual threshold levels can be determined through conducting a double-blind placebo-controlled food challenge (DBPCFC) at an allergist’s office and administering increasing amounts of the offending substance disguised with other food materials in order to determine its lowest observed adverse effect level (NOAEL).
Threshold levels on a population-wide level, such as those used in risk analyses and regulatory authorities, provide invaluable information for managing food allergies. These threshold values generally refer to the maximum dose of an allergen that would not trigger reactions among an allergic population of predetermined size; typically defined using the Eliciting Dose Parameters (EDp), an estimate of how much allergen protein must be present to trigger an objective allergic response from at least five percent or more of all allergic individuals in an allergy population.
The threshold approach has been approved by the Codex Alimentarius Commission and included into the General Standard for Labelling of Packaged Foods (GSLPF). It aims to limit allergy declarations such as “may contain” warnings to instances when food poses a clear risk to allergic consumers; it won’t however provide protection for very small numbers of sensitive consumers who react even to smaller allergen amounts than the NOAEL or RfD can account for.
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