Plastic waste continues to draw global attention. Phthalates are chemical additives widely used in the plastics industry as plasticizers to make plastics more flexible and durable. They can be found in nail polish, medical products, household items, cosmetics, building materials, and food product packaging.
Many agencies and publications have long identified phthalates as chemicals of concern due to their potential to contribute to health effects such as endocrine disruption and hormone-related impacts. Much of the literature on toxicity and health effects is based on animal and in vitro (artificial environment) studies. Despite the increasing research on potential health effects, human epidemiological reviews have shown inadequate evidence of a direct relationship between phthalate exposure and adverse health effects.
On December 31, 2025, the United States Environmental Protection Agency (EPA) announced the regulation of five commonly used phthalates under the Toxic Substances Control Act (TSCA): Butyl Benzyl Phthalate (BBP), Dibutyl Phthalate (DBP), Dicyclohexyl Phthalate (DCHP), Diethylhexyl Phthalate (DEHP), and Diisobutyl Phthalate (DIBP). The EPA concluded that certain occupational inhalation exposures during manufacturing presented an “unreasonable risk,” and that four of the five chemicals released by specific industries pose hazards to aquatic life.
Manufacturers and suppliers should be aware that EPA’s phthalate initiatives may affect product formulation and supply chains, covering both existing and replacement parts. This could limit certain uses and impact product liability and market access, further complicating the process of adapting to new regulations. Understanding the scope of restricted uses early creates an opportunity to proactively assess materials, engage in supply chain partners, and explore compliant alternatives.
It is noteworthy that the EPA’s evaluation acknowledged that adverse health effects are dose related. EPA does not assess exposures from food and food packaging, cosmetics, medical devices, or other consumer products overseen by the Food and Drug Administration (FDA), or the Consumer Product Safety Commission (CPS). For consumer uses that are normally under TSCA, such as textiles, leather goods, and lawn care, EPA did not identify exposure levels posing an unreasonable risk to consumers or the general population.
On May 27, 2026, the FDA announced the scientific evaluation of eight phthalates currently permitted as plasticizers for food contact use. The reassessment was intended to determine whether these phthalates should be grouped together in risk assessment based on their chemical and pharmacological similarities. This development may have important implications for manufacturers that use or source food-contact materials. Even before the FDA takes further regulatory action, the review may increase pressure on both retailers and customers to achieve greater transparency regarding the use of phthalates in food-contact applications.
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When toxicological, epidemiological, and mechanistic data are considered together, the weight of evidence does not indicate that phthalate exposures at the typical evaluated levels are associated with adverse health effects in the applications assessed.
When TSCA evaluations move forward, the likelihood for litigation focused on consumer and worker protection increases. This makes a rigorous, well-documented risk assessment approach more important than ever. Organizations that invest in scientifically defensible exposure evaluations now will be better positioned to respond to regulatory scrutiny and legal challenges as they emerge.
TRC’s tested practitioners, including Dr. Dennis Paustenbach, PhD, CIH, DABT, and Kenneth Unice, MS, AIGP, have experience in toxicology, industrial hygiene, and human health risk assessment related to phthalates and plasticizers. Our team applies exposure to science and health risk assessment methodologies to evaluate the hazards posed by airborne toxicants, including phthalates and their derivatives, in various environments.
