Allergens: A Potential Kiss of Death

“One of the major considerations is cross-contact. That term means inadvertent contact,” she says, citing a chocolatier that makes both the plain and peanut variety under the same roof as an example.

Labeling requirements, however, do not apply to major food allergens that are unintentionally added to a food as the result of cross-contact, which occurs when “residue or other trace amounts of an allergenic food is unintentionally incorporated into another food that is not intended to contain that allergenic food.”

The FDA indicates that cross-contact may result from customary methods of growing and harvesting crops, as well as from the use of shared storage, transportation or production equipment.

The new law, however, does not establish any particular provisions to address cross-contact and how it is to be handled.

“It strictly focuses on labeling,” the FDA official says of FALCPA.

According to the FDA, the law applies to all packaged foods sold in the U.S. that are regulated under the Food, Drug & Cosmetic Act (FD&C), including both domestically manufactured and imported foods. Raw agricultural commodities such as fresh fruits and vegetables are not affected by the mandate.

While the law only applies to food regulated by the FDA under the FD&C Act, producers of meat, poultry and egg products get legislation and guidance from USDA.

The USDA directive requires food manufacturers to indicate 12 groups of potential allergens by reference to the source allergen if they are used as an ingredient at any level in pre-packed foods, including alcoholic drinks.

The new rules also abolishes the “25 percent rule,” under which it was not mandatory to label components of compound ingredients if they made up less than 25 percent of the final food product. The new allergen labeling rules were fully implemented as of Nov. 25. Products not complying with the new legislation will be prohibited for sale in the European Union.

The list of potential allergenic ingredients and associated products include: Cereals containing gluten, crustacean, eggs, fish, peanuts, soybeans, milk and dairy products, nuts and nut products, celery, mustard and products thereof, sesame seeds and sculpture dioxide and sulfites at concentrations of more than 10 mg/kg or 10 mg/l expressed as SO2.

Vexing Verbiage

The operative word when it comes to allergens and food products is “contains.”

If a “contains” statement is used on a food label, the statement must include the names of the food sources of all major food allergens used as ingredients in the packaged food, the FDA stipulates.

“For example, if sodium caseinate, whey, egg yolks and natural peanut flavor are declared in a product’s ingredients list, any ‘contains’ statement appearing on the label immediately after or adjacent to that statement is required to identify all three sources of the major food allergens present (e.g., ‘Contains milk, eggs, peanuts’) in the same type (i.e., print or font) size as that used for the ingredient list,” the CFSAN guidance indicates.

CFSAN even provides guidance on wording, noting that the verbiage for a “contains” statement may be limited to just stating the word followed by the names of the food sources of all major allergens that are in the ingredients of the packaged product.

On the other hand, the FDA indicates, additional wording may be used for a “contains” statement to more accurately describe the presence of any major food allergens, provided that the following three conditions are met:

• The word “contains” with a capital “C” must be the first word used to begin a “contains” statement. (The use of bolded text and punctuation within a “contains” statement is optional.)
• The names of the food sources of the major food allergens declared on the food label must be the same as those specified in the FALCPA, except that the names of food sources may be expressed using singular terms versus plural terms (e.g., walnut versus walnuts) and the synonyms “soy” and “soya” may be substituted for the food source name “soybeans.”
• If included on a food label, the “contains” statement must identify the names of the food sources for all major food allergens that either are in the food or are contained in ingredients of the food.

Are there penalties for non-compliance?

You bet, says the FDA. Under the FD&C Act, a company and its management may be subject to civil sanctions, criminal penalties or both if the firm’s packaged food products do not comply with labeling requirements.