European Plasticisers comments on recent publications by Radke et al (2018) and Bornehag et al (2018)

In the past weeks, two publications by Radke et al (2018) “Phthalate exposure and male reproductive outcomes: A systematic review of the human epidemiologic evidence”[1], and by Bornehag et al (2018) “Association of Prenatal Phthalate Exposure with Language Development in Early Childhood”[2], have received some media attention.


European Plasticisers considers that some points concerning these studies should be addressed and corrected.


Regarding Radke et al:

  • This is a review of existing and already extensively assessed epidemiological studies related to six phthalates, both those classified for adverse reproductive effects (DEHP, DBP, DIBP, BBP) and those not classified for such effects, following regulatory assessments (DEP, DINP).
  • The review by Radke et al (2018) is not “led by the US Environmental Protection Agency” as stated by Chemical Watch, but as stated in the paper itself “ The views expressed are those of the authors and do not necessarily represent the views or policies of the U.S. EPA.”
  • The Radke et al conclusion of “moderate evidence” of an association between DINP exposure and male reproductive outcomes, has been reached by using an own and non-validated method to evaluate study quality. The publication also makes arbitrary judgements for overall hazard and does not include a review of the extensive database of animal studies on DINP showing a lack of adverse reproductive effects. The conclusions of Radke et al (2018) are therefore not supported by the data.
  • Based on a review of all available epidemiological studies as well as animal data (the latter are not taken into account by Radke et al), the recent ECHA RAC opinion (March 2018) concluded that “no classification for DINP for either effects on sexual function and fertility, or for developmental toxicity is warranted”.


Moreover, the same RAC opinion clearly states that for epidemiological studies relevant to fertility “There is no evidence for effects of DINP on fertility in human”; and for epidemiological studies relevant to developmental effects”: “RAC noted that no clear-cut conclusions can be drawn from the epidemiological studies”. In particular, concerning human data, “among a large number of possible associations between exposure levels and reproductive endpoints, some positive associations were found which were possibly due to random error”.


As a consequence, for developmental effects, “Based on the existing epidemiological studies, no clear conclusions on possible effects of DINP exposure on male reproductive organs or other endpoints can be drawn”[3].


In their own review, Radke et al do not consider the above-mentioned ECHA RAC opinion based on a three-year assessment of all the available data.


Cefic European Plasticisers and the ACC High Phthalates Panel, are now drafting a letter to the Editor of Environment International, where the paper was published in July 2018, in order to address the inaccuracies and correct the conclusions accordingly.


Concerning the study by Bornehag et al (2018) “Association of Prenatal Phthalate Exposure with Language Development in Early Childhood”, the combination of the results published by Eriksson et al (2012)[4] with the differences in European phthalate exposure levels published by Den Hond et al (2015)[5] implies that, contrary to the claims by Bornehag et al, phthalate exposure levels of children living in Europe do not influence language or communication skill developments in children.


A letter will be sent to the Editor of JAMA Pediatrics to address the inaccuracies and flaws in the publication.