Because plasticisers (US: plasticizers) are so widely used, they have undergone extensive testing for possible health and environmental effects and are among the most widely researched of all chemical substances. In Europe, the safe use of plasticisers is enabled by REACH, the most comprehensive product safety regulation anywhere in the world.
Since the implementation of REACH in 2007, approximately 50 plasticisers (US: plasticizers) have been registered. Consumers can benefit from the use of plasticisers in flexible PVC applications, and at the same time be reassured of the high level of safety of the products they are using.
Very often, in media and public debates, research studies are presented as showing potential links between plasticisers (US: plasticizers) and health or environmental concerns. However, in most cases, these studies are specifically focused on low molecular weight ortho-phthalates and their metabolites. At the same time, results showing correlation tend to be misinterpreted as causation, which leads to unfounded alarmism and scaremongering.
Claiming that all plasticisers (US: plasticizers), or a particular type of plasticisers, have negative effects just based on the analysis of one molecule would be like saying that all cholesterol is bad. Generalisations, although frequently used to make a concept more easily understood, can be misleading when talking about complex scientific issues and should therefore be avoided.
To date, only four classified low ortho-phthalates – DEHP, DBP, DIBP and BBP – have been found to have any adverse endocrine-related effects in laboratory animal studies with specific thresholds. The adverse effects on the reproductive system of rats are adverse endocrine effects since the reproductive system is an endocrine system. However, for substances to be considered as endocrine disruptors a causal link with the endocrine mechanism and the adverse effects should be demonstrated; as yet this has not been demonstrated by regulators but is currently under review.
These substances are already on the REACH Candidate and Authorisation Lists and Authorisation has been recommended for DEHP and DBP based on adequate control; no Authorisation request for DIBP and BBP has been made and these substances and will not continue to be used in Europe as of February 2015 for REACH related applications.
All other plasticisers, including high molecular weight ortho-phthalates, are not classified for any adverse health effects and do not cause adverse effects via an endocrine mechanism – hence they are not endocrine disruptors. The same conclusion has been reached by European Plasticisers’ expert scientists who, using OECD’s endocrine evaluation framework, have clearly shown that high phthalates are not endocrine disrupters.
Most recently, ECHA has finalized a 4 year re-evaluation of the hazard and exposure data for two of the most widely used phthalate plasticisers, DINP and DIDP, including extensive reproductive and endocrine data. The conclusion is that the health effects to be used in risk assessments for these substances are mild liver effects observed in rats.