Regulatory Issues: Allergen labeling in plain English

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Both houses of Congress have passed a bill intended to improve the manner in which allergens are identified on food labels. At the time of this writing, these provisions are expected to be signed into law by the President shortly and will be known as the Food Allergen Labeling and Consumer Protection Act of 2004. The law will require minor changes in the ingredient declaration for some foods, effective for foods that are labeled on or after Jan. 1, 2006.

The law identifies eight major food allergens: milk, eggs, fish, shellfish, tree nuts, peanuts, wheat and soybeans. The labeling requirement is fairly simple. If a food is one of these things or contains an ingredient or additive derived from one of them, the food must be labeled with the name of the allergen. So, for example, if a product contains whey, the ingredient declaration will need to make it clear that whey is derived from milk.

This requirement also extends to certain additives that have not always been identified
You also need
to identify additives that may not have been identified in the past if they are derived from one of the
eight allergens.
on food labels in the past, such as incidental additives (processing aids and carryover additives that do not function in the finished food), and additives that have been covered by a collective name in the past, such as “natural flavors.” The collective name can still be used, but if one of the natural flavors present in a particular food was derived from one of the eight major allergens, it will need to be identified.

In a nutshell: You need to use plain English and you need to identify additives that may not have been identified in the past if they are derived from one of the eight allergens. No more casein, semolina, albumen or lactoglobulin standing alone in ingredient lists.

There’s an exception to the general rule described above. Any “highly refined oil” derived from one of the eight major food allergens is not treated as an allergenic ingredient. The thinking behind this exception is that highly refined oils should not contain protein from the allergenic source such that an allergic reaction would be triggered. Of course, in many cases (and maybe in just about all cases), the “common or usual name” of the oil would include its source. Thus, peanut oil and soybean oil have been and will continue to be identified by those names. Furthermore, if a manufacturer is in doubt as to whether or not an allergenic protein is present in a refined oil, it would seem prudent to identify the source of the oil.

Two mechanisms (petition or notification) are available to establish that a particular food ingredient derived from one of the eight major allergens does not produce allergic reactions.

Many food manufacturers are already labeling their products in accordance with these requirements. Both the food industry and consumer advocates have generally supported this law as a sensible effort to make life easier for individuals who suffer from food allergies.

What the Law Does Not Require

The law does not mandate specific steps that must be taken to avoid the accidental contamination of food with allergens. If a food processing facility handles allergenic ingredients, such as peanuts, and also produces foods that are not intended to contain allergens, the facility currently has an obligation to avoid cross-contamination as a matter of good manufacturing practices (GMPs). Many food processing facilities currently go to great lengths to segregate allergenic ingredients.

The new law does not specifically address this issue except that it requires the Secretary of Health and Human Services (HHS) to report to Congress on the issue 18 months after the act is signed into law. It is sensible to have HHS (and more specifically the Food and Drug Administration) study this issue and consider whether any rules or recommendations are appropriate. This is certainly preferable to having Congress attempt to legislate specific requirements in this area.

The new law also does not address advisory labeling such as “may contain peanuts,” except that it directs HHS to review the extent to which and conditions under which this type of labeling is used and whether it is helpful to consumers with allergies. This is a complex issue on which a balance might be sought considering such things as the degree to which cross-contamination can be realistically prevented even using state-of-the-art GMPs.

David Joy is a partner at the Washington, D.C. law firm of Keller and Heckman LLP. He specializes in food and drug law with emphasis on the domestic and international regulation of food, food additives, food labeling, antimicrobial pesticides, and medical devices. He is a member of the District of Columbia Bar and holds a bachelor’s degree in chemistry. For more information about Keller and Heckman, visit the firm’s web site at www.khlaw.com.

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