Occurrence and dietary exposure to phthalates in the US population - a contextual review

Esters of 1,2-benzene dicarboxylic acid (or phthalates) are general purpose plasticizers used in multiple polyvinyl chloride (PVC) consumer applications. Some of these plasticizers are permitted for safe use in a narrow subset of food packaging applications by global regulatory agencies, including the US FDA. Several US studies have reported the presence of trace concentrations of phthalates (parts per billion) in the diet. These findings have prompted calls for regulatory action based on the potential for adverse impacts on public health. These claims are misguided. Global food safety regulatory frameworks are designed with the expectation that low concentrations of food contact materials may be present in food. These frameworks include guardrails (in the form of content limits and/or migration limits) to minimize the potential for dietary risk. This concept of exposure and risk is often missing in many studies identifying low concentrations of phthalates in food. Dietary risk assessments, based on total diet studies, have been published by food safety agencies in the EU, Australia, New Zealand, UK, and Canada. Without exception, all risk assessments confirm that concentrations of phthalates in food are low and do not pose a public health concern. In this review, we calculate dietary risk estimates for concentrations of high molecular weight phthalates reported in some US food articles. The results confirm that dietary exposures, even in the most conservative scenarios, are below levels of concern.