Phthalates are primarily used as plasticizers in polyvinyl chloride (PVC) and polyvinylidene chloride (PVDC) polymers to increase their flexibility. FDA authorizes the use of some phthalates in flexible food packaging made from PVC and PVDC.
As it pertains to the packaging material for boxed macaroni and cheese, the packaging itself would not contain phthalates as these products do not require softening agents.
There are a wide variety of authorized applications where phthalates can be used in food contact materials but there are three main regulated classes, polymers, adhesives and metal coatings. These include an addition to certain polymers (PVC) where the concentration added is in percent quantities to make them flexible and crack resistant, i.e., hoses, conveyor belts, plastic films. They can be added to packaging adhesives for flexibility. Packaging adhesives require a barrier between the adhesive and the food. Phthalates can also be added to coatings applied to protect metal surfaces such as can coatings and storage tanks. Moreover, phthalates in the environment can be found in many non-food related products.
Various phthalates are permitted to be used in specified food contact substances as allowed by regulation. FDA would look at the exposure levels in the food to determine if the levels were in excess of what would be expected from migration from an authorized use in the product’s processing equipment or packaging. Where no limits are specified in an applicable food additive regulation, 21 CFR 174.5 limits a number of phthalates that may be added in food contact applications to good manufacturing practices (the minimum amount necessary to achieve the intended technical effect).
The FDA, as a science-driven regulatory agency, requires, under the food additive provisions of the Federal Food, Drug, and Cosmetic Act, that there must be a reasonable certainty of no harm from food ingredients. Food packaging, components of which can migrate into food, must be found safe for their intended use before they can be marketed. Specifically, there must be sufficient scientific information to demonstrate that the use of a substance in food contact materials is safe under the intended conditions of use before it is authorized for those uses. For food contact substances, which includes substances used in packaging, the FDA’s safety evaluations generally focus on dietary exposure to the food contact substance, as well as available toxicity information on the substance, in order to determine if the exposure from the intended use is safe.
The FDA continues to evaluate available information on a food additive after its approved and as new data becomes available. If our review of existing data no longer supports the continued safe use of these materials in food contact material, FDA will take appropriate regulatory action to remove these materials from the marketplace.
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