Food allergen in the EU and in the US


lcmm@melchionnalaw.com
Food allergen in the EU and in the US

Food allergen labeling requirements in the EU and USA are similar in principle as they are meant to reach the same results: adequately inform consumers, protect their health, and truthfully disclose all products and ingredients that directly or indirectly are used. However, there are some differences.  

In the USA, the primary food allergen labeling legislation is the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA). FALCPA governs allergen labeling requirements for all FDA-regulated consumer-packaged foods but does not cover poultry, most meats, certain egg products, or most alcoholic beverages. There are currently no federal allergen labeling requirements for the excluded foods.

If a food product contains what FALCPA calls one of 8 “major food allergens,” its label must have a “Contains” statement the same font and size as a food’s ingredients list in which it names the allergen’s source food. These major food allergens, which account for 90% of all severe food allergen reactions, are milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts, and soybeans. A whey protein powder jug, for example, must include on its label “whey” as an ingredient and a “Contains milk” statement separate from its ingredients list. In the case of tree nuts, fish, and crustacean shellfish, the specific animal/plant the Act requires the species to be named rather than the food group (e.g. “walnuts, cod, or lobster.” rather than “tree nuts, fish, and crustacean shellfish.”).

Although it is encouraged by the FDA, FALCPA does not regulate or require the use of statements like “may contain”, “traces of” and/or “product in a facility that handles …” These statements are voluntary and used at the manufacturer’s discretion.

However, there are exceptions to the above regulations for raw agricultural commodities, highly refined oils (or their derivatives), and single ingredient foods. While the first two are exempt entirely from allergen labeling requirements, manufacturers may indicate major food allergens on single ingredient food packaging in one of two ways: They may either use the traditional “Contains” statement, ideally located somewhere on the primary display panel, as is normally required, or they may use the major allergen food source in the food name (e.g. “all-purpose wheat flour”).

In the European Union, food allergen labeling is covered by the Food Information for Consumers Regulation (“FIC”) (EU Regulation No.1169/2011). According to the FIC, all food businesses, regardless of food product or whether they serve prepackaged or non-prepackaged food, must declare any of following 14 major food allergens in a conspicuous place: Cereals containing gluten; Crustaceans; Eggs; Fish; Peanuts; Soybeans; Milk; Nuts; Celery; Mustard; Sesame; Sulphur dioxide; Lupin; and Mollusks.

Although there is no agreed upon set of icons or symbols to indicate the presence of these allergens, the major food allergens must be indicated distinguishably in the food’s ingredients list. A product containing the allergen milk, for example, can say both “skimmed milk” and “whey powder (milk).” The regulation sets a principle – that allergens must be labeled clearly (Commission Notice 2017/C 428/01) – but leaves the display methodology to each food business. For non-prepackaged foods only, member states are permitted to adopt national measures to ensure the 14 major food allergens are displayed uniformly.

There are two situations in which the EU requires food allergens to be labeled in the same manner as the USA: First, foods exempt from having an ingredients lists must have a “Contains” statement if they contain one of the 14 major food allergens. Second, foods containing nuts must declare the specific type of nut it contains.

EU and USA labeling laws differ in both scope and means. In terms of scope, the FIC applies to all consumer foods in the EU, whereas FALCPA applies only to prepacked foods regulated by the FDA where regulations affect fewer foods and fewer allergens. In terms of means, allergens in the EU must be declared in the ingredients list in some distinguishable way; in the USA, allergens must be listed in a discrete “Contains” statement on the food’s packaging.