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Food companies itching for answers

FDA is slow to address question of allergen labeling in packaging.
FILED IN:  Machinery  > Labeling

The new allergen labeling law that kicks in January 1 may prove a kick in the pants for some kinds of packaging. Major food companies have pretty much had their food product labels redone to indicate the presence of any of eight major food allergens in their foods as prescribed by the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA).

But those same companies barring a last minute reprieve from the Food and Drug Administration will also have to list the allergens contained in their packaging if the packaging comes into contact with the food. The FALCPA identifies eight major food allergens or food groups: milk eggs fish (e.g. bass flounder cod) crustacean shellfish (e.g. shrimp crab lobster) tree nuts (e.g. almonds walnuts pecans) peanuts wheat and soybeans.

Almost all paperboard and plastic packaging contains soy-derived glues and polymers wheat-derived starches for glues and coatings and casein-derived coatings or additives. The FDA has expressly authorized 36 soy-derived indirect food additives as safe for use. The American Forest and Paper Assn. acknowledges that a broad range of paperboard food packages contain low levels of allergen-derived substances.

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Blanket exemption?

Marci Cleary senior manager communication International Dairy Foods Assn. says her member companies are looking to the FDA to address the issue of allergens in packaging. “They have not addressed it to this point” Cleary adds. And they may not address it anytime soon.

On August 18 the FDA’s Center for Food Safety and Nutrition announced it was moving its allergen compliance and enforcement strategy from an “A” priority to a “B” priority. Cleary explains that milk ice cream and other manufacturers have already relabeled products to indicate the presence of allergens but not those in paperboard packaging they use.

A number of packaging trade groups such as the American Forest and Paper Assn. and Paperboard Packaging Council (PPC) are urging the FDA to endorse a blanket exemption for all packaging. Melissa Teates director of industry information and research for the PPC says her group believes Congress never intended for allergens in packaging to be noted on food labels. “Packaging should be completely exempt that is what we want” she emphasizes.

The FDA is unlikely to grant such an exemption. Instead according to a senior official the agency will probably issue guidance which is advisory.

‘Major’ allergens?

This official who declines to be identified acknowledges that the agency has thought about the issue of packaging allergens and “is getting phone calls and letter inquiries.” The FALCPA refers to ingredients that are major allergens. “In the past we have not called packaging components that migrate into food ‘ingredients’” she explains. The FDA guidance when issued may cover the meaning of “ingredient.”

But FALCPA does require food labels to note the presence of incidental additives the FDA official says. Packaging components could be considered incidental additives. Again this would ostensibly be covered by guidance. “We are acutely aware of the timeframe” she states referring to the January 1 deadline.


A blanket exemption for packaging would take care of the confusion and the cost for having to relabel foods to indicate packaging allergens. But that is not likely to be forthcoming. And any guidance on the subject issued prior to January 1 will be open to considerable interpretation.

Exemption process

So the packaging issue may be in flux until the FDA starts considering formal applications for exemption from the FALCPA. This requires the agency to set up a process where companies can use one of two processes to apply for an individual exemption for a particular ingredient. Under the petition process an ingredient may be exempt if the petitioner demonstrates that the ingredient “does not cause an allergic reaction that poses a risk to human health.”

Under the notification process an ingredient may be exempt if the notification contains scientific evidence that demonstrates that the ingredient “does not contain allergenic protein” or if FDA previously has determined the food ingredient does not cause an allergic response that poses a risk to human health.

Both exemptions depend on the FDA determining a method for establishing a threshold below which the allergen poses no danger. But this exemption process will not be in place by January 1 2006 and probably not any time soon after that.

John Festa senior scientist at the American Forest Products Assn. says it is unreasonable to expect paperboard vendors (working in conjunction with the food companies themselves) to pursue individual exemptions for individual paperboard packages.

“A large number of individual petitions or notifications would need to be submitted with respect to each such use of allergen-derived substances including data on the amount of allergenic protein in each substance and migration from each type of package or food-contact substance” explains Festa.

No evidence

“The immense burden that would be imposed upon manufacturers of paperboard food packaging and food-contact substances is plainly unjustified in the absence of any evidence that these substances have ever been responsible for an allergic reaction in food-allergic consumers” Festa states.

In asking for a blanket exemption John Burke president of the Foodservice & Packaging Institute Inc. says history is on his side. “In the case of single-use packaging or single-use food-contact substances we do not know of any reported incidence of these items being cited as causing an allergenic reaction in the hundred-year history of the industry” says Burke.

The incidental snaring of packaging in the allergen labeling law is similar to what happened when the FDA wrote rules implementing the 2003 Bioterrorism Act. There the issue was whether the packaging apart from the food could become a target for terrorist sabotage.

In one instance packagers were successful in arguing that the law did not intend food importers to notify the FDA when overseas shipments of packaging arrived on U.S. shores. In another instance however food marketers were forced starting at the beginning of this year to be able to match up shipments of imported packaging with the products they are used for.

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