Substance specific studies: All the studies presented as showing potential endocrine disruptive effects for phthalates specifically focus on low molecular weight phthalates and their metabolites. Claiming that all phthalates are reprotoxic based just on the analysis of one main molecule would be like saying that all cholesterol is bad, whereas it is well known that there is good and bad cholesterol. 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.
Phthalate migration: High molecular weight phthalates 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, phthalates would remain tightly locked. It is a misconception that all phthalates used in PVC readily migrate. If this was 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.
Indoor air and dust: It is very important to emphasize that the presence of flexible PVC particles in house dust does not pose any risks to human health. Recent scientific studies have concluded that household dust does not correlate to human exposure levels for phthalates, 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.
Presence of phthalates in cosmetics: Regarding the use of EU classified low molecular weight phthalates, only DBP and DIBP were ever used in cosmetics or body care products but are no longer found in products manufactured and commercialised in the European Union due to provisions of the European Cosmetics legislation, which prohibits the use of substances classified for carcinogenic, mutagenic and repro-toxic (CMR) hazards. This EU legislation does not apply in other regions of the world, such as the US, where the use of these phthalates is still permitted, although some companies have voluntarily stopped using them. High phthalates are not used simply because their technical properties and molecular structure do not make them suitable for cosmetics applications. Today, only the non-classified phthalates, DMP and DEP are used in cosmetics in the EU. They have not been classified or restricted because they do not pose any risks for our health or the environment
Animal studies: Those bundling together all phthalates and labelling them as endocrine disruptors often refer to animal studies showing adverse effects even for high phthalates. Comprehensive animal studies have shown that high phthalates do not cause adverse effects via an endocrine mechanism. While effects are seen on rats’ liver at very high doses (3000 to 20,000 times higher than the maximum potential exposure to humans), these are not endocrine related effects.
REACH regulation: Amidst growing concerns regarding exposure to chemicals, some groups are calling for new legislation to limit their use in Europe. However, it is important to recall that phthalates are among the most widely researched and carefully regulated substances. The EU Regulation on chemicals and their safe use, REACH, is the most comprehensive chemical safety regulation in the world. The use of classified phthalates has declined significantly over the last 20 years and today, around 85% of all phthalates produced in Europe are non-classified high molecular weight substances which have been registered under REACH.
Industry’s responsibility: The entire chemical industry takes its responsibility for ensuring the safe use of its substances and products and for complying with all relevant legislation very seriously. Plasticisers in general, and phthalates in particular, have been extensively tested and evaluated including for potential adverse effects via an endocrine mechanism. The chemical industry, which has a lot at stake in the endocrine debate, continuously sponsors broad and product specific research to address this important issue. Funding is available via the Long Range Research Initiative managed by CEFIC and from specific sector groups.
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