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FLEXO Magazine : September 2014
One Size Does Not Fit All Safety Assessments for Special Types of Food Packages Joan Sylvain Baughan W hen 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 as- sessments of food contact materials. For higher levels of potential ex- posure to a substance, more toxicity data is 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 CONTACT AREA CALCULATION For most typical packages, FDA uses a “default” assumption—that each square inch surface area of the package comes into contact with 10-g. of food—to calculate the concentration of substances that may migrate from the package. This default assumption is not necessarily accurate when special packages, such as single serve stickpacks, are in- volved. In such cases, the amount of packaging surface area in contact with a given quantity of food can vary, leading to varying concentra- tions 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 sensi- tivities 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 six 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. 16 FLEXO | SEPTEMBER 2014 LEGAL WRAP New Feature