Allergen Fact Sheets are an indispensable asset to food businesses looking to comply with allergen-information requirements set out by the Food Standards Code.
Law requires food labels to disclose eight major food allergens that account for 90% of allergies and severe allergic reactions; these are milk, egg, soy, wheat, fish, Crustacean shellfish (crab), peanuts and tree nuts.
The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA)
The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) makes it easier for those with food allergies to identify and avoid foods that might trigger reactions. Food companies must clearly mark packaged products containing major allergens; this law covers items produced within the U.S. as well as imported ones.
Under FALCPA, food labels must contain both the common or usual name of a major allergen and its food source in parentheses following each initial mention of that ingredient. If an ingredient’s common or usual name already identifies its major allergen, no need to repeat itself in this list. Furthermore, the law also mandates that specific species of fish such as bass flounder cod or cod and specific crustacean shellfish species (crab lobster shrimp etc) used must also be identified on an ingredients list; mollusks however do not need to be listed separately.
Under FALCPA, anyone may petition the FDA for an exemption from its labeling requirements if scientific data demonstrates that a food ingredient and production method do not cause allergic reactions which pose significant threats to human health. The FDA maintains an inventory of exemption notifications received under FALCPA here.
The Food and Drug Administration (FDA)
The Food and Drug Administration is responsible for overseeing the safety of foods, medical products, tobacco, and tobacco-related items sold within the US. They are well known for establishing rules pertaining to clinical trials before new drugs can be sold on the market and for detecting undeclared allergens within foods.
History of FDA The history of FDA dates back to 1906 when Congress passed the Pure Food and Drug Act. Under this act were created several divisions to manage all aspects of food, drugs, cosmetics, animal feed, and dietary supplement products and administration of duties assigned by FDA including food products; cosmetics; animal feed; dietary supplements.
As part of its duties, the FDA must uphold federal laws and regulations it oversees as well as test and approve production facilities that make products such as pharmaceuticals, dietary supplements, electronic radiation emitting devices, blood products etc.
The FDA maintains a database that tracks major allergens found in food products and works with companies to recall them if undeclared allergens are discovered. In addition to labeling prepacked and unprepacked foods in such a way as to inform consumers of possible allergens present, as well as preventing cross-contact between allergens during manufacturing processes, the agency also oversees cross-contact prevention measures during food manufacturing processes.
The Food Safety and Inspection Service (FSIS)
FSIS, as part of the United States Department of Agriculture (USDA), is an agency responsible for assuring that commercial meat, poultry and egg products in the United States are safe, wholesome and appropriately labeled and packaged. FSIS derives its authority from three acts – The Federal Meat Inspection Act, Poultry Products Inspection Act and Egg Product Inspection Act.
Not only does the EU regulate animal slaughtering, it also oversees the manufacture of processed meat and poultry. To achieve this goal it has established a system of meat inspection as well as mandating companies develop laboratory methods for detecting undeclared allergens in their foods – methods which other laboratories then use when testing food samples for such hidden allergens.
At both stages of the ordering process, customers should have access to allergen information – when placing their order and when picking it up. You can achieve this by listing allergens clearly on your menu or posting a sign advising them they can contact your staff with allergy related inquiries.
FSIS developed a system for tracking and identifying these allergens after several major food recalls were caused by undeclared allergens in various products. It utilizes a database of common allergens to quickly identify any potential issues before checking recalled items against this list.
The Food and Drug Administration’s (FDA’s) Food Allergen Database
Food allergens listed under the Food, Drug, and Cosmetic Act must be disclosed on product labels; however, the list does not contain all foods that cause allergic reactions in sensitive individuals. As part of its evaluation of whether regulatory requirements should be set for non-listed allergens not listed under FDCA, FDA released draft guidance in October for evaluating public health importance as part of determining a regulatory requirement to establish new ones in this regard.
Draft guidance suggests that an allergen program for companies should include supplier approval and verification activities, with food manufacturers having procedures in place to monitor labeling controls for unintended food allergens at their facility, segregating allergen-containing raw materials or ingredients from those without allergens before opening, weighting and transporting them to production areas, as well as tracking all products that contain specified allergens with clear identification labels on them.
Recent RFR reports from 2007-2012 indicated that bakery products, snack foods, and candy were most frequently the source of undeclared major food allergen recalls due to undeclared major allergens. Milk was the most frequently undeclared allergen; peanuts came second. Sometimes this happened because shared equipment or failure to identify an ingredient as allergenic was at fault (e.g. chocolate-coated snack bars labeled “dairy-free” or “vegan” were mistakenly assumed not containing an allergenic ingredient).
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