One Size Does Not Fit All: Safety Assessments for Special Types of Food Packages

September 9, 2014

By Keller and Heckman LLP’s Packaging Practice Group

When regulatory authorities assess the safety of food packaging materials, unique features such as special sizes, shapes, and target audiences can play an important role. This is because a safety evaluation of a packaging material involves consideration of how unique features may affect exposure to the materials used to produce the packaging, and how exposure to those materials may impact sensitive populations, such as infants and small children.

The U.S. Food and Drug Administration (FDA) applies a tiered approach to the toxicity data requirements for supporting safety assessments of food-contact materials. For higher levels of potential exposure to a substance, more toxicity are data needed to support safety.

Exposure to a food packaging material is estimated based on:

  • The amount of the material that contacts and can potentially migrate into a given amount of food
  • The portion of the diet that is packaged using that material
  • The amount of food consumed in comparison to the body weight of the consumer

For most typical packages, FDA uses a "default" assumption—that each square inch surface area of the package comes into contact with 10 grams of food—to calculate the concentration in food of substances that may migrate from the package. This default assumption is not necessarily accurate when special packages, such as single serve stick packs, are involved. In such cases, the amount of packaging surface area in contact with a given quantity of food can vary, leading to varying concentrations of migrating substances in the food. Furthermore, these types of packages are becoming more common for foods that are consumed by special populations, such as infants, whose eating patterns and sensitivities differ from those of the general, "adult" population.

With respect to infant formula, for example, this may account for 100 percent of an infant's diet until the age of 6 months and thus, the same packaging materials conceivably could come into contact with 100 percent of a baby's diet. Even after solid foods are introduced, the infant's diet remains relatively limited, so that infant or toddler food supplied in a specific type of packaging, like stickpacks, may represent a large portion of the child's diet.

For the general adult population, on the other hand, any given food would account for only a fraction of the overall diet, so that any given type of packaging would be expected to come into contact with no more than a fraction of the diet. Moreover, due to the baby's rapid rate of growth, an infant consumes a greater amount of food than an adult in comparison to its body weight, further differentiating exposure levels to packaging materials.

For these reasons, and due to concerns about enhanced sensitivity during crucial stages of development, FDA recently has begun to separately review the safety of new food-contact materials for use in applications involving infant formula.

Modern Language

FDA's new focus on performing separate safety evaluations of packaging materials for infant formula becomes apparent when reviewing the Agency's website listings for effective Food Contact Notifications. Many—indeed, most—recent FCN clearances now include language limiting the scope of the clearances to exclude infant formula packaging, or to indicate that the safety of the material for use with infant formula has not been evaluated.

This type of language should not be read to indicate that the use of the substance poses any safety concerns, however; it is simply indicative of the fact that FDA is applying new factors in evaluating infant exposures and, for the most part, the companies that submitted the recent FCNs were not aware of the new parameters when preparing their FCNs and did not provide the necessary exposure and safety assessment.

Going forward, producers of new materials intended for use with infant formula will need to estimate dietary exposures using the factors unique to infants and ensure that there are sufficient toxicology data to support the safety of the resulting exposures. Indeed, companies developing new food packaging materials are well advised always to consider any special considerations, such as novel sizes or target audiences, when performing safety assessments.

The following article appeared in FLEXO® Magazine's September 2014 issue.