Food-Contact Packaging Materials May Force Products to Need Allergen Labeling

Date: Feb 01, 2006

The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), which went into effect on January 1, 2006, requires more complete and clearer labeling of foods that contain the eight most common food allergens or ingredients with intact protein that are derived from them. However, because the law does not establish any thresholds for labeling-and the Food and Drug Administration (FDA) has not otherwise provided guidance-food companies have been left in a quandary on how to account for components of packaging that are derived from one of the eight allergens.

The eight major food allergens currently covered by FALCPA are: (1) milk; (2) eggs; (3) fish (such as, bass, flounder or cod); (4) crustacean shellfish (such as, crab, lobster or shrimp); (5) tree nuts (such as, almonds, pecans or walnuts); (6) wheat; (7) peanuts; and (8) soybeans.

Food products that consist of one or more of the listed foods or that contain ingredients that bear or contain (or are derived from) one of these foods must be labeled to indicate the presence of the allergen in plain English.

The problem is that some materials used in packaging may also be derived from these allergens. For example, some types of paperboard and plastic packaging may contain soy-derived glues or resins, wheat-derived starches or casein-derived coatings or additives.

Although FALCPA exempts highly refined oils processed from any of the major food allergens and derivatives thereof, no other types of refined or processed materials are similarly exempt. To obtain an exemption, food companies have to petition FDA, and demonstrate that, although the food ingredient contains allergenic protein, it does not cause an allergic response that poses a risk to human health.

Food companies have expressed concern to FDA that the law as written would require labeling for ingredients derived from a listed allergen even if present at such low levels as not to pose a realistic concern, and have suggested that the FDA establish thresholds below which labeling would not be required. Industry is concerned that, without such thresholds, over-labeling will result, unnecessarily reducing an allergen sufferer's food choices.

The FDA also has been asked to clarify the status of packaging under the FALCPA, with the agency being urged to grant a blanket exemption from FALCPAlabeling requirements for all packaging materials. However, guidance from the FDA, on this matter, has so far not been forthcoming. Until FDA acts to provide such guidance or industry petitions FDA for formal exemptions, either broad-based or for specific types of materials or additives, individual companies will need to assess the potential for allergen-derived proteins to be in a packaging material and therefore whether labeling of the product on that account will be necessary.

Used with permission. Copyright FOOD & DRUG PACKAGING, February, 2006.

For further information about this article, please contact George G. Misko at 202-434-4170 or by email at misko@khlaw.com.