On November 15, 2021, the peer-reviewed scientific journal Environmental Health published an article about “The role of epidemiology in risk assessment: a case study of five ortho-phthalates” by Maricel Maffini, independent scientist, US, and co-authors, including scientists from the Food Packaging Forum, Swiss Federal Institute of Aquatic Science and Technology (Eawag), and University of Gothenburg.
The study highlights two important aspects: Firstly, current regulatory safe limits for phthalates have been set based on male reproductive toxicity, assuming that these health effects were the most sensitive. However, the present study shows that this assumption may not be appropriate and that regulatory limits should be revised considering these recent findings. And secondly, the re-assessment of chemicals already on the market for many decades, like the phthalates, needs to be carried out using epidemiological data, where available, to complement toxicological studies. Human data should always be considered more relevant than studies in experimental animals for setting safe human exposure levels.
The authors reviewed the scientific literature on human exposures to five priority chemicals of concern from the group of the ortho-phthalates: benzyl butyl phthalate (BBP; CAS 85-68-7), diisobutyl phthalate (DIBP; CAS 84-69-5), dibutyl phthalate (DBP; CAS 84-74-2), dicyclohexyl phthalate (DCHP; CAS 84-61-7), and bis(2-ethylhexyl) phthalate (DEHP; CAS 117-81-7). The study’s authors estimated oral intake of the chemicals based on human urine levels reported in 38 epidemiological studies from different human populations and recorded the respective health effects observed at those exposure levels. These estimates were then compared to regulatory limits for the different compounds. This showed that some human health effects observed in diverse human populations (children, men and women) occur at levels up to 8000 times below the assumed “safe” exposure limits. Observed health effects below the safe exposure levels were reproductive, neurodevelopmental, behavioral, hormonal, and metabolic.
The study by Maffini and colleagues adds to several other recent publications on various phthalates of concern, estimating the health costs of phthalate exposures by Trasande et al. (FPF reported), and systematically reviewing the human health effects of phthalates by Eales, Galloway et al. (FPF reported). Another recent scientific publication showed that phthalate exposure from fast food packaging in the US is significant (FPF reported). Further, the European Food Safety Authority (EFSA) is currently reviewing its regulatory safe limits for the phthalates of concern and has opened its draft scientific opinion for public comment (FPF reported). And the US Environmental Protection Agency (US EPA) is in the process of setting safe limits for the phthalates investigated in this study (FPF reported).
The Food Packaging Forum is holding a webinar on November 19, 2021 with Drs. Jacqui Eales, Tamara Galloway, Maricel Maffini, and Leonardo Trasande who will discuss their recent studies and discuss implications for policymakers and regulators. A full recording of the event will be made freely available on the event’s page.
Maffini, MV., Geueke, B., Groh, K., Carney Almroth, B., Muncke, J. (2021). “The role of epidemiology in risk assessment: a case study of five ortho-phthalates.” Environmental Health. DOI: 10.1186/s12940-021-00799-8
Joshua Poole (November 16, 2021). “Safety first: Phthalate chemicals present human health threats beyond regulatory “safe” limits, study finds.” Packaging Insights
Huanjia Zhang (November 17, 2021). “Phthalates’ regulatory standards may not protect people’s health, new study.” Environmental Health News
Emma Davies (November 25, 2021). “Phthalates study suggests regulatory risk assessments should routinely account for epidemiology.” Chemical Watch