Health misconceptions

Some plasticisers and classified low molecular weight orthophthalates in particular, have been under the spotlight in media and public debates due to their health effects. However, it is crucial to keep in mind that there are lots of different plasticisers with very different composition, effects, applications and regulatory status. Using all-encompassing, generic terms such as “plasticisers” or “phthalates” in referring to health and environmental hazards and risks is simply not correct. Some of the conditions most commonly cited in association with plasticisers include:

Asthma

It is very important to emphasize that the presence of flexible PVC particles in house dust does not pose any risks to human health. Plasticisers do not readily migrate or leach into the environment from articles because they are physically bound within the PVC matrix. Even in abraded particles that may be collected in the form of dust, plasticisers would remain tightly bound within the PVC matrix. If this was not the case, flexible PVC would not remain flexible and perform as intended. Essential applications such as wire and cable, where electrical safety is paramount, would crack and break rendering them unusable and potentially unsafe for consumers.

Reports linking exposure to phthalates and asthma are often based on finding a correlation, which does not mean causation.

In addition, recent scientific studies have concluded that household dust does not correlate to human exposure levels, and is not an indicator of indoor air quality (1). It is therefore not scientifically sound to conclude that levels in dust equate to exposure and therefore exceed safe limits.

Carcinogenicity

In today’s flexible PVC, there is not a single plasticiser being used which has been found to be carcinogenic for humans. Extensive research has shown that cancers seen in animal studies with orthophthlates are not relevant to humans. This research has been reviewed by regulators in Europe who confirmed this conclusion of lack of human relevance. In addition, it should also be noted that plasticisers – including phthalates – bind tightly within the plastic material and do not readily migrate. They are not absorbed via the skin or saliva as. Even if placed in the mouth, it requires prolonged chewing for the plasticisers to be released.

Endocrine disruption

To date, only four classified low orthophthalates – 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 orthophthalates, 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.

Obesity

There have been studies and media reports claiming that obesity could be linked to exposure to phthalate plasticisers used in cosmetics. Today, only the non-classified DMP and DEP are used in cosmetics in the EU because they have not been classified or restricted because they do not pose any risks for our health or the environment.

In the past, EU classified low phthalates DBP and DIBP were employed in cosmetics and body care products but are no longer found in articles produced and commercialised in the European Union due to provisions of the European Cosmetics legislation, which prohibits the use of substances classified as carcinogenic, mutagenic or repro-toxic (CMR).  Non-classified phthalates are not used in this type of applications.

There is no good evidence that exposure to phthalates or other chemicals contributes to obesity – this is simply scaremongering. Lifestyle factors including diet, exercise, smoking, and alcohol consumption are major factors in determining the health of human populations. There is no robust evidence that the very low levels of exposure to chemicals which typically occurs in consumers is contributing to the disease burden of human populations. In fact the contrary is true and chemicals make a positive contribution to health via the myriad benefits they bring to society such as for example safe and hygienic food as well as in healthcare. Occupational Health and Safety controls are of course very important for people working in the chemical industry where there is potential for significant exposure.

1. H. Fromme et al., “Occurrence of phthalates and musk fragrances in indoor air and dust from apartments and kindergartens in Berlin (Germany), Indoor Air 2003, 1-8. Kerstin Becker et al. “DEHP metabolites in urine of children and DEHP in house dust”. International Journal of Hygiene and Environmental Health 207 (2004); 409-417. Tobias Schripp et al. “Chamber studies on mass-transfer of di(2-ethylhexyl)phthalate (DEHP) and di-n-butylphthalate (DnBP) from emission sources into house dust”, Atmospheric Environment 44 (2010) ECPI Scientific Working Group Report 110301 – “Endocrine Data Evaluation Report” – March 2011